Trial Outcomes & Findings for A 1-year Trial to Inform About Long-term Exposure to Eptinezumab in Participants With Chronic Cluster Headache (cCH) (NCT NCT05064397)
NCT ID: NCT05064397
Last Updated: 2024-08-06
Results Overview
A treatment-emergent AE was defined as any on-treatment untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A summary of non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
131 participants
Primary outcome timeframe
From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
Results posted on
2024-08-06
Participant Flow
Participant milestones
| Measure |
Eptinezumab
Participants received 4 intravenous (IV) infusions of 400 milligrams (mg) eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
|
|---|---|
|
Overall Study
STARTED
|
131
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
131
|
|
Overall Study
COMPLETED
|
108
|
|
Overall Study
NOT COMPLETED
|
23
|
Reasons for withdrawal
| Measure |
Eptinezumab
Participants received 4 intravenous (IV) infusions of 400 milligrams (mg) eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Lack of Efficacy
|
12
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Other reasons
|
3
|
Baseline Characteristics
A 1-year Trial to Inform About Long-term Exposure to Eptinezumab in Participants With Chronic Cluster Headache (cCH)
Baseline characteristics by cohort
| Measure |
Eptinezumab
n=131 Participants
Participants received 4 IV infusions of 400 mg eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
|
|---|---|
|
Age, Continuous
|
45.2 years
STANDARD_DEVIATION 10.79 • n=99 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
76 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
51 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From the day of first dose of study drug (Baseline [Week 0]) up to Week 56Population: The APTS included all participants who received infusion with eptinezumab.
A treatment-emergent AE was defined as any on-treatment untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A summary of non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Outcome measures
| Measure |
Eptinezumab
n=131 Participants
Participants received 4 IV infusions of 400 mg eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
|
|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (AEs)
|
106 Participants
|
SECONDARY outcome
Timeframe: Week 1 to Week 48Population: The Full Analysis Set (FAS) included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks.
Participants counted as converting from cCH to eCH if they had no CH attacks for at least 3 months.
Outcome measures
| Measure |
Eptinezumab
n=131 Participants
Participants received 4 IV infusions of 400 mg eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
|
|---|---|
|
Conversion From Chronic Cluster Headache (cCH) to Episodic Cluster Headache (eCH): Number of Participants With No Cluster Headache (CH) Attacks for ≥3 Consecutive Months (≥12 Consecutive Weeks)
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluable at each specified time point.
Abortive therapy was defined as oxygen and/or triptans, where it counted as 2 times if oxygen and triptans were used for the same attack.
Outcome measures
| Measure |
Eptinezumab
n=127 Participants
Participants received 4 IV infusions of 400 mg eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
|
|---|---|
|
Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used
Week 1
|
-3.63 Abortive therapy use per week
Standard Error 0.53
|
|
Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used
Week 2
|
-4.24 Abortive therapy use per week
Standard Error 0.70
|
|
Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used
Week 3
|
-4.90 Abortive therapy use per week
Standard Error 0.76
|
|
Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used
Week 4
|
-4.99 Abortive therapy use per week
Standard Error 0.94
|
|
Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used
Week 13
|
-7.22 Abortive therapy use per week
Standard Error 0.84
|
|
Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used
Week 14
|
-6.83 Abortive therapy use per week
Standard Error 0.85
|
|
Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used
Week 15
|
-6.06 Abortive therapy use per week
Standard Error 0.84
|
|
Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used
Week 16
|
-6.42 Abortive therapy use per week
Standard Error 0.96
|
|
Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used
Week 25
|
-6.18 Abortive therapy use per week
Standard Error 0.99
|
|
Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used
Week 26
|
-6.56 Abortive therapy use per week
Standard Error 0.86
|
|
Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used
Week 27
|
-7.56 Abortive therapy use per week
Standard Error 0.82
|
|
Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used
Week 28
|
-7.12 Abortive therapy use per week
Standard Error 0.83
|
|
Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used
Week 37
|
-6.55 Abortive therapy use per week
Standard Error 0.98
|
|
Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used
Week 38
|
-6.97 Abortive therapy use per week
Standard Error 0.84
|
|
Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used
Week 39
|
-6.71 Abortive therapy use per week
Standard Error 1.04
|
|
Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used
Week 40
|
-7.09 Abortive therapy use per week
Standard Error 0.84
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluable at each specified time point.
Outcome measures
| Measure |
Eptinezumab
n=127 Participants
Participants received 4 IV infusions of 400 mg eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
|
|---|---|
|
Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used
Week 1
|
-1.72 Oxygen use per week
Standard Error 0.33
|
|
Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used
Week 2
|
-2.43 Oxygen use per week
Standard Error 0.40
|
|
Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used
Week 3
|
-3.17 Oxygen use per week
Standard Error 0.48
|
|
Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used
Week 4
|
-3.23 Oxygen use per week
Standard Error 0.59
|
|
Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used
Week 13
|
-3.97 Oxygen use per week
Standard Error 0.57
|
|
Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used
Week 14
|
-3.93 Oxygen use per week
Standard Error 0.56
|
|
Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used
Week 15
|
-3.09 Oxygen use per week
Standard Error 0.53
|
|
Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used
Week 16
|
-3.78 Oxygen use per week
Standard Error 0.61
|
|
Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used
Week 25
|
-3.56 Oxygen use per week
Standard Error 0.67
|
|
Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used
Week 26
|
-3.75 Oxygen use per week
Standard Error 0.58
|
|
Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used
Week 27
|
-4.06 Oxygen use per week
Standard Error 0.52
|
|
Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used
Week 28
|
-4.02 Oxygen use per week
Standard Error 0.54
|
|
Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used
Week 37
|
-3.60 Oxygen use per week
Standard Error 0.64
|
|
Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used
Week 38
|
-3.74 Oxygen use per week
Standard Error 0.52
|
|
Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used
Week 39
|
-3.99 Oxygen use per week
Standard Error 0.66
|
|
Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used
Week 40
|
-3.82 Oxygen use per week
Standard Error 0.55
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluable at each specified time point.
Outcome measures
| Measure |
Eptinezumab
n=127 Participants
Participants received 4 IV infusions of 400 mg eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
|
|---|---|
|
Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used
Week 39
|
-2.52 Triptans use per week
Standard Error 0.58
|
|
Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used
Week 40
|
-2.95 Triptans use per week
Standard Error 0.54
|
|
Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used
Week 1
|
-1.75 Triptans use per week
Standard Error 0.33
|
|
Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used
Week 2
|
-1.73 Triptans use per week
Standard Error 0.42
|
|
Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used
Week 3
|
-1.74 Triptans use per week
Standard Error 0.44
|
|
Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used
Week 4
|
-1.90 Triptans use per week
Standard Error 0.45
|
|
Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used
Week 13
|
-2.94 Triptans use per week
Standard Error 0.46
|
|
Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used
Week 14
|
-2.78 Triptans use per week
Standard Error 0.50
|
|
Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used
Week 15
|
-2.81 Triptans use per week
Standard Error 0.49
|
|
Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used
Week 16
|
-2.50 Triptans use per week
Standard Error 0.51
|
|
Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used
Week 25
|
-2.05 Triptans use per week
Standard Error 0.52
|
|
Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used
Week 26
|
-2.48 Triptans use per week
Standard Error 0.48
|
|
Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used
Week 27
|
-3.06 Triptans use per week
Standard Error 0.45
|
|
Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used
Week 28
|
-2.86 Triptans use per week
Standard Error 0.46
|
|
Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used
Week 37
|
-2.55 Triptans use per week
Standard Error 0.50
|
|
Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used
Week 38
|
-2.54 Triptans use per week
Standard Error 0.49
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluable at each specified time point.
The participant completed a CH eDiary, daily, and record for each day/week whether he/she had any CH attacks.
Outcome measures
| Measure |
Eptinezumab
n=127 Participants
Participants received 4 IV infusions of 400 mg eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
|
|---|---|
|
Change From Baseline in the Average Number of Weekly Attacks
Week 1
|
-3.00 Attacks per week
Standard Error 0.54
|
|
Change From Baseline in the Average Number of Weekly Attacks
Week 2
|
-3.92 Attacks per week
Standard Error 0.79
|
|
Change From Baseline in the Average Number of Weekly Attacks
Week 3
|
-4.51 Attacks per week
Standard Error 0.93
|
|
Change From Baseline in the Average Number of Weekly Attacks
Week 4
|
-4.98 Attacks per week
Standard Error 1.18
|
|
Change From Baseline in the Average Number of Weekly Attacks
Week 13
|
-6.18 Attacks per week
Standard Error 1.20
|
|
Change From Baseline in the Average Number of Weekly Attacks
Week 14
|
-6.31 Attacks per week
Standard Error 1.15
|
|
Change From Baseline in the Average Number of Weekly Attacks
Week 15
|
-5.81 Attacks per week
Standard Error 1.08
|
|
Change From Baseline in the Average Number of Weekly Attacks
Week 16
|
-6.63 Attacks per week
Standard Error 1.24
|
|
Change From Baseline in the Average Number of Weekly Attacks
Week 25
|
-5.56 Attacks per week
Standard Error 1.26
|
|
Change From Baseline in the Average Number of Weekly Attacks
Week 26
|
-5.95 Attacks per week
Standard Error 1.27
|
|
Change From Baseline in the Average Number of Weekly Attacks
Week 27
|
-7.09 Attacks per week
Standard Error 1.22
|
|
Change From Baseline in the Average Number of Weekly Attacks
Week 28
|
-6.51 Attacks per week
Standard Error 1.31
|
|
Change From Baseline in the Average Number of Weekly Attacks
Week 37
|
-6.25 Attacks per week
Standard Error 1.27
|
|
Change From Baseline in the Average Number of Weekly Attacks
Week 38
|
-6.57 Attacks per week
Standard Error 1.14
|
|
Change From Baseline in the Average Number of Weekly Attacks
Week 39
|
-5.99 Attacks per week
Standard Error 1.23
|
|
Change From Baseline in the Average Number of Weekly Attacks
Week 40
|
-6.39 Attacks per week
Standard Error 1.15
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 1-4Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
The average of the estimated change from baseline in the number of weekly attacks across the first 4 weeks after the infusion is shown.
Outcome measures
| Measure |
Eptinezumab
n=127 Participants
Participants received 4 IV infusions of 400 mg eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
|
|---|---|
|
Change From Baseline in the Number of Weekly Attacks
|
-4.11 Attacks per week
Standard Error 0.79
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 1-2Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
The average of the estimated change from baseline in the number of weekly attacks across the first 2 weeks after the infusion is shown.
Outcome measures
| Measure |
Eptinezumab
n=127 Participants
Participants received 4 IV infusions of 400 mg eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
|
|---|---|
|
Change From Baseline in the Number of Weekly Attacks
|
-3.46 Attacks per week
Standard Error 0.61
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Months 1-12Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
The average of the estimated change from baseline in the number of monthly attacks across the first 12 months after the infusion is shown.
Outcome measures
| Measure |
Eptinezumab
n=129 Participants
Participants received 4 IV infusions of 400 mg eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
|
|---|---|
|
Change From Baseline in the Number of Monthly Attacks
|
-22.65 Attacks per month
Standard Error 4.39
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluable at each specified time point.
The severity of pain for each attack was rated on an ordinal scale that ranged from 0 to 4 with higher scores indicating more headache pain (headache pain ratings: 0 = none/barely any pain; 1 = mild; 2 = moderate; 3 = severe; 4 = excruciating).
Outcome measures
| Measure |
Eptinezumab
n=127 Participants
Participants received 4 IV infusions of 400 mg eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
|
|---|---|
|
Change From Baseline in the Average Attack Related Daily Pain (Including Days With no Attacks), as Assessed Using the 5-point Self-rating Pain Severity Scale
Week 1
|
-0.47 score on a scale
Standard Error 0.06
|
|
Change From Baseline in the Average Attack Related Daily Pain (Including Days With no Attacks), as Assessed Using the 5-point Self-rating Pain Severity Scale
Week 2
|
-0.51 score on a scale
Standard Error 0.07
|
|
Change From Baseline in the Average Attack Related Daily Pain (Including Days With no Attacks), as Assessed Using the 5-point Self-rating Pain Severity Scale
Week 3
|
-0.58 score on a scale
Standard Error 0.07
|
|
Change From Baseline in the Average Attack Related Daily Pain (Including Days With no Attacks), as Assessed Using the 5-point Self-rating Pain Severity Scale
Week 4
|
-0.59 score on a scale
Standard Error 0.08
|
|
Change From Baseline in the Average Attack Related Daily Pain (Including Days With no Attacks), as Assessed Using the 5-point Self-rating Pain Severity Scale
Week 13
|
-0.78 score on a scale
Standard Error 0.09
|
|
Change From Baseline in the Average Attack Related Daily Pain (Including Days With no Attacks), as Assessed Using the 5-point Self-rating Pain Severity Scale
Week 14
|
-0.75 score on a scale
Standard Error 0.09
|
|
Change From Baseline in the Average Attack Related Daily Pain (Including Days With no Attacks), as Assessed Using the 5-point Self-rating Pain Severity Scale
Week 15
|
-0.82 score on a scale
Standard Error 0.08
|
|
Change From Baseline in the Average Attack Related Daily Pain (Including Days With no Attacks), as Assessed Using the 5-point Self-rating Pain Severity Scale
Week 16
|
-0.90 score on a scale
Standard Error 0.09
|
|
Change From Baseline in the Average Attack Related Daily Pain (Including Days With no Attacks), as Assessed Using the 5-point Self-rating Pain Severity Scale
Week 25
|
-0.80 score on a scale
Standard Error 0.09
|
|
Change From Baseline in the Average Attack Related Daily Pain (Including Days With no Attacks), as Assessed Using the 5-point Self-rating Pain Severity Scale
Week 26
|
-0.79 score on a scale
Standard Error 0.09
|
|
Change From Baseline in the Average Attack Related Daily Pain (Including Days With no Attacks), as Assessed Using the 5-point Self-rating Pain Severity Scale
Week 27
|
-0.88 score on a scale
Standard Error 0.09
|
|
Change From Baseline in the Average Attack Related Daily Pain (Including Days With no Attacks), as Assessed Using the 5-point Self-rating Pain Severity Scale
Week 28
|
-0.84 score on a scale
Standard Error 0.09
|
|
Change From Baseline in the Average Attack Related Daily Pain (Including Days With no Attacks), as Assessed Using the 5-point Self-rating Pain Severity Scale
Week 37
|
-0.77 score on a scale
Standard Error 0.09
|
|
Change From Baseline in the Average Attack Related Daily Pain (Including Days With no Attacks), as Assessed Using the 5-point Self-rating Pain Severity Scale
Week 38
|
-0.79 score on a scale
Standard Error 0.10
|
|
Change From Baseline in the Average Attack Related Daily Pain (Including Days With no Attacks), as Assessed Using the 5-point Self-rating Pain Severity Scale
Week 39
|
-0.70 score on a scale
Standard Error 0.10
|
|
Change From Baseline in the Average Attack Related Daily Pain (Including Days With no Attacks), as Assessed Using the 5-point Self-rating Pain Severity Scale
Week 40
|
-0.79 score on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluable at each specified time point.
Outcome measures
| Measure |
Eptinezumab
n=127 Participants
Participants received 4 IV infusions of 400 mg eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
|
|---|---|
|
Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks
Week 1
|
49 Participants
|
|
Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks
Week 2
|
52 Participants
|
|
Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks
Week 3
|
55 Participants
|
|
Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks
Week 4
|
55 Participants
|
|
Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks
Week 13
|
54 Participants
|
|
Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks
Week 14
|
63 Participants
|
|
Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks
Week 15
|
58 Participants
|
|
Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks
Week 16
|
62 Participants
|
|
Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks
Week 25
|
60 Participants
|
|
Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks
Week 26
|
60 Participants
|
|
Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks
Week 27
|
62 Participants
|
|
Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks
Week 28
|
48 Participants
|
|
Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks
Week 37
|
57 Participants
|
|
Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks
Week 38
|
51 Participants
|
|
Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks
Week 39
|
43 Participants
|
|
Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks
Week 40
|
44 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluable at each specified time point.
Outcome measures
| Measure |
Eptinezumab
n=127 Participants
Participants received 4 IV infusions of 400 mg eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
|
|---|---|
|
Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks
Week 1
|
30 Participants
|
|
Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks
Week 2
|
36 Participants
|
|
Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks
Week 3
|
42 Participants
|
|
Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks
Week 4
|
40 Participants
|
|
Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks
Week 13
|
35 Participants
|
|
Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks
Week 14
|
45 Participants
|
|
Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks
Week 15
|
43 Participants
|
|
Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks
Week 16
|
48 Participants
|
|
Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks
Week 25
|
43 Participants
|
|
Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks
Week 26
|
45 Participants
|
|
Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks
Week 27
|
45 Participants
|
|
Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks
Week 28
|
39 Participants
|
|
Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks
Week 37
|
40 Participants
|
|
Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks
Week 38
|
41 Participants
|
|
Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks
Week 39
|
34 Participants
|
|
Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks
Week 40
|
38 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluable at each specified time point.
Outcome measures
| Measure |
Eptinezumab
n=127 Participants
Participants received 4 IV infusions of 400 mg eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
|
|---|---|
|
Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks
Week 1
|
11 Participants
|
|
Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks
Week 2
|
13 Participants
|
|
Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks
Week 3
|
21 Participants
|
|
Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks
Week 4
|
20 Participants
|
|
Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks
Week 13
|
23 Participants
|
|
Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks
Week 14
|
25 Participants
|
|
Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks
Week 15
|
23 Participants
|
|
Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks
Week 16
|
29 Participants
|
|
Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks
Week 25
|
29 Participants
|
|
Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks
Week 26
|
24 Participants
|
|
Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks
Week 27
|
28 Participants
|
|
Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks
Week 28
|
24 Participants
|
|
Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks
Week 37
|
27 Participants
|
|
Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks
Week 38
|
28 Participants
|
|
Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks
Week 39
|
21 Participants
|
|
Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks
Week 40
|
25 Participants
|
SECONDARY outcome
Timeframe: Week 1 to Week 48Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluable at each specified time point.
Participants counted as being in remission if they had no cluster headache attacks for at least 1 month.
Outcome measures
| Measure |
Eptinezumab
n=131 Participants
Participants received 4 IV infusions of 400 mg eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
|
|---|---|
|
cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks)
|
19 Participants
|
SECONDARY outcome
Timeframe: Week 1 to Week 12Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluable at each specified time point.
Outcome measures
| Measure |
Eptinezumab
n=129 Participants
Participants received 4 IV infusions of 400 mg eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
|
|---|---|
|
cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Between the First and Second Infusion)
|
8 Participants
|
SECONDARY outcome
Timeframe: Week 13 to Week 24Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluable at each specified time point.
Outcome measures
| Measure |
Eptinezumab
n=119 Participants
Participants received 4 IV infusions of 400 mg eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
|
|---|---|
|
cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Between the Second and Third Infusion)
|
10 Participants
|
SECONDARY outcome
Timeframe: Week 25 to Week 36Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluable at each specified time point.
Outcome measures
| Measure |
Eptinezumab
n=111 Participants
Participants received 4 IV infusions of 400 mg eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
|
|---|---|
|
cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Between the Third and Fourth Infusion)
|
9 Participants
|
SECONDARY outcome
Timeframe: Week 37 to Week 48Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
Outcome measures
| Measure |
Eptinezumab
n=104 Participants
Participants received 4 IV infusions of 400 mg eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
|
|---|---|
|
cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Within the First 12 Weeks After the Fourth Infusion)
|
10 Participants
|
SECONDARY outcome
Timeframe: Week 1 to Week 48Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks.
Transitional treatments were defined as greater occipital nerve (GON) block or oral steroids.
Outcome measures
| Measure |
Eptinezumab
n=131 Participants
Participants received 4 IV infusions of 400 mg eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
|
|---|---|
|
Number of Participants Who Received a Transitional Therapy During the Treatment Period
|
17 Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluable at each specified time point.
The PGIC is a patient-reported measure of improvement in pain sensation and quality of life scored on a scale from 1 (very much improved) to 7 (very much worse). Lower scores indicate better health status.
Outcome measures
| Measure |
Eptinezumab
n=118 Participants
Participants received 4 IV infusions of 400 mg eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
|
|---|---|
|
Patient Global Impression of Change (PGIC) Score
Week 32
|
2.64 score on a scale
Standard Error 0.13
|
|
Patient Global Impression of Change (PGIC) Score
Week 4
|
2.74 score on a scale
Standard Error 0.12
|
|
Patient Global Impression of Change (PGIC) Score
Week 8
|
2.69 score on a scale
Standard Error 0.13
|
|
Patient Global Impression of Change (PGIC) Score
Week 12
|
2.69 score on a scale
Standard Error 0.13
|
|
Patient Global Impression of Change (PGIC) Score
Week 16
|
2.58 score on a scale
Standard Error 0.13
|
|
Patient Global Impression of Change (PGIC) Score
Week 20
|
2.72 score on a scale
Standard Error 0.14
|
|
Patient Global Impression of Change (PGIC) Score
Week 24
|
2.58 score on a scale
Standard Error 0.13
|
|
Patient Global Impression of Change (PGIC) Score
Week 28
|
2.54 score on a scale
Standard Error 0.13
|
|
Patient Global Impression of Change (PGIC) Score
Week 36
|
2.58 score on a scale
Standard Error 0.12
|
|
Patient Global Impression of Change (PGIC) Score
Week 40
|
2.73 score on a scale
Standard Error 0.14
|
|
Patient Global Impression of Change (PGIC) Score
Week 44
|
2.67 score on a scale
Standard Error 0.13
|
|
Patient Global Impression of Change (PGIC) Score
Week 48
|
2.65 score on a scale
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 4, 12, 16, 24, 28, 36, 40, 48Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluable for each specified category.
The SIS is a patient-reported clinical outcome assessment used to assess quality of life resulting from sleep disturbance. The SIS questionnaire includes 35 items belonging to 7 domains to assess sleep impact on: daily activities; emotional well-being; emotional impact; energy/fatigue; social well-being; mental fatigue; and satisfaction with sleep. Each item, for 6 out of the 7 domains, is rated on a 5-point scale ranging from 1 (always or all of the time) to 5 (never or none of the time), whereas satisfaction with sleep is rated on a 5-point scale ranging from 1 (very satisfied) to 5 (very dissatisfied). Each domain yields a score ranging from 0 to 100, which is presented here. A higher score for Daily Activities, Emotional Well-being, Emotional Impact, Energy/Fatigue, Social Well-being, and Mental Fatigue indicates better quality of life. A lower score for Satisfaction with Sleep indicates a higher quality of life.
Outcome measures
| Measure |
Eptinezumab
n=109 Participants
Participants received 4 IV infusions of 400 mg eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
|
|---|---|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Daily Activities - Week 4
|
14.98 score on a scale
Standard Deviation 2.05
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Daily Activities - Week 12
|
15.26 score on a scale
Standard Deviation 2.36
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Daily Activities - Week 16
|
16.36 score on a scale
Standard Deviation 2.48
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Daily Activities - Week 24
|
15.54 score on a scale
Standard Deviation 2.33
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Daily Activities - Week 28
|
16.17 score on a scale
Standard Deviation 2.42
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Daily Activities - Week 36
|
14.51 score on a scale
Standard Deviation 2.39
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Daily Activities - Week 40
|
17.83 score on a scale
Standard Deviation 2.15
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Daily Activities - Week 48
|
13.29 score on a scale
Standard Deviation 2.34
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Emotional Well-being - Week 4
|
17.63 score on a scale
Standard Deviation 2.19
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Emotional Well-being - Week 12
|
16.28 score on a scale
Standard Deviation 2.32
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Emotional Well-being - Week 16
|
15.72 score on a scale
Standard Deviation 2.37
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Emotional Well-being - Week 24
|
14.04 score on a scale
Standard Deviation 2.47
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Emotional Well-being - Week 28
|
17.98 score on a scale
Standard Deviation 2.51
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Emotional Well-being - Week 36
|
15.75 score on a scale
Standard Deviation 2.34
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Emotional Well-being - Week 40
|
15.40 score on a scale
Standard Deviation 2.35
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Emotional Well-being - Week 48
|
14.61 score on a scale
Standard Deviation 2.53
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Emotional Impact - Week 4
|
17.41 score on a scale
Standard Deviation 2.42
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Emotional Impact - Week 12
|
17.00 score on a scale
Standard Deviation 2.48
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Emotional Impact - Week 16
|
18.34 score on a scale
Standard Deviation 2.59
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Emotional Impact - Week 24
|
17.01 score on a scale
Standard Deviation 2.42
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Emotional Impact - Week 28
|
20.78 score on a scale
Standard Deviation 2.53
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Emotional Impact - Week 36
|
16.53 score on a scale
Standard Deviation 2.53
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Emotional Impact - Week 40
|
17.21 score on a scale
Standard Deviation 2.57
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Emotional Impact - Week 48
|
15.61 score on a scale
Standard Deviation 2.58
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Energy/Fatigue - Week 4
|
16.00 score on a scale
Standard Deviation 2.35
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Energy/Fatigue - Week 12
|
16.67 score on a scale
Standard Deviation 2.50
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Energy/Fatigue - Week 16
|
16.87 score on a scale
Standard Deviation 2.63
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Energy/Fatigue - Week 24
|
16.59 score on a scale
Standard Deviation 2.71
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Energy/Fatigue - Week 28
|
19.67 score on a scale
Standard Deviation 2.73
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Energy/Fatigue - Week 36
|
15.93 score on a scale
Standard Deviation 2.62
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Energy/Fatigue - Week 40
|
19.16 score on a scale
Standard Deviation 2.53
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Energy/Fatigue - Week 48
|
17.65 score on a scale
Standard Deviation 2.62
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Social Well-being - Week 4
|
14.73 score on a scale
Standard Deviation 2.06
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Social Well-being - Week 12
|
15.28 score on a scale
Standard Deviation 2.31
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Social Well-being - Week 16
|
14.68 score on a scale
Standard Deviation 2.55
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Social Well-being - Week 24
|
14.59 score on a scale
Standard Deviation 2.46
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Social Well-being - Week 28
|
17.30 score on a scale
Standard Deviation 2.64
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Social Well-being - Week 36
|
13.27 score on a scale
Standard Deviation 2.43
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Social Well-being - Week 40
|
15.59 score on a scale
Standard Deviation 2.42
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Social Well-being - Week 48
|
14.13 score on a scale
Standard Deviation 2.59
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Mental Fatigue - Week 4
|
13.00 score on a scale
Standard Deviation 2.23
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Mental Fatigue - Week 12
|
15.00 score on a scale
Standard Deviation 2.34
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Mental Fatigue - Week 16
|
15.15 score on a scale
Standard Deviation 2.27
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Mental Fatigue - Week 24
|
13.57 score on a scale
Standard Deviation 2.39
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Mental Fatigue - Week 28
|
14.86 score on a scale
Standard Deviation 2.36
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Mental Fatigue - Week 36
|
13.64 score on a scale
Standard Deviation 2.49
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Mental Fatigue - Week 40
|
13.98 score on a scale
Standard Deviation 2.39
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Mental Fatigue - Week 48
|
13.55 score on a scale
Standard Deviation 2.42
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Satisfaction With Sleep - Week 4
|
-13.86 score on a scale
Standard Deviation 2.25
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Satisfaction With Sleep - Week 12
|
-13.47 score on a scale
Standard Deviation 2.29
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Satisfaction With Sleep - Week 16
|
-14.50 score on a scale
Standard Deviation 2.40
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Satisfaction With Sleep - Week 24
|
-12.30 score on a scale
Standard Deviation 2.20
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Satisfaction With Sleep - Week 28
|
-16.67 score on a scale
Standard Deviation 2.39
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Satisfaction With Sleep - Week 36
|
-13.95 score on a scale
Standard Deviation 2.43
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Satisfaction With Sleep - Week 40
|
-14.99 score on a scale
Standard Deviation 2.60
|
|
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Satisfaction With Sleep - Week 48
|
-14.19 score on a scale
Standard Deviation 2.59
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 4, 16, 28, 40, 48Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluable for each specified category.
The EQ-5D-5L is a patient-reported assessment designed to measure the participant's well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety). Each descriptive item is rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems).
Outcome measures
| Measure |
Eptinezumab
n=97 Participants
Participants received 4 IV infusions of 400 mg eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
|
|---|---|
|
Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48
Mobility - Week 48
|
-0.0 score on a scale
Standard Deviation 0.90
|
|
Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48
Mobility - Week 4
|
0.1 score on a scale
Standard Deviation 0.89
|
|
Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48
Self Care - Week 4
|
0.0 score on a scale
Standard Deviation 0.47
|
|
Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48
Usual Activities - Week 4
|
-0.2 score on a scale
Standard Deviation 1.13
|
|
Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48
Pain/Discomfort - Week 4
|
-0.1 score on a scale
Standard Deviation 1.28
|
|
Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48
Anxiety/Depression - Week 4
|
-0.1 score on a scale
Standard Deviation 0.70
|
|
Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48
Mobility - Week 16
|
0.1 score on a scale
Standard Deviation 1.02
|
|
Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48
Self Care - Week 16
|
0.0 score on a scale
Standard Deviation 0.69
|
|
Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48
Usual Activities - Week 16
|
-0.2 score on a scale
Standard Deviation 1.07
|
|
Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48
Pain/Discomfort - Week 16
|
-0.2 score on a scale
Standard Deviation 1.48
|
|
Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48
Anxiety/Depression - Week 16
|
-0.1 score on a scale
Standard Deviation 0.98
|
|
Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48
Mobility - Week 28
|
0.1 score on a scale
Standard Deviation 0.92
|
|
Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48
Self Care - Week 28
|
0.1 score on a scale
Standard Deviation 0.65
|
|
Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48
Usual Activities - Week 28
|
-0.1 score on a scale
Standard Deviation 1.14
|
|
Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48
Pain/Discomfort - Week 28
|
-0.1 score on a scale
Standard Deviation 1.26
|
|
Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48
Anxiety/Depression - Week 28
|
-0.1 score on a scale
Standard Deviation 0.98
|
|
Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48
Mobility - Week 40
|
0.0 score on a scale
Standard Deviation 0.96
|
|
Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48
Self Care - Week 40
|
0.0 score on a scale
Standard Deviation 0.49
|
|
Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48
Usual Activities - Week 40
|
-0.4 score on a scale
Standard Deviation 1.04
|
|
Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48
Pain/Discomfort - Week 40
|
-0.3 score on a scale
Standard Deviation 1.42
|
|
Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48
Anxiety/Depression - Week 40
|
-0.1 score on a scale
Standard Deviation 0.97
|
|
Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48
Self Care - Week 48
|
0.0 score on a scale
Standard Deviation 0.53
|
|
Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48
Usual Activities - Week 48
|
-0.2 score on a scale
Standard Deviation 1.17
|
|
Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48
Pain/Discomfort - Week 48
|
-0.1 score on a scale
Standard Deviation 1.24
|
|
Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48
Anxiety/Depression - Week 48
|
-0.0 score on a scale
Standard Deviation 1.04
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 4, 16, 28, 40, 48Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluable at each specified time point.
The EQ-5D-5L VAS is a participant-reported assessment designed to measure the participant's well-being and ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
Outcome measures
| Measure |
Eptinezumab
n=97 Participants
Participants received 4 IV infusions of 400 mg eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
|
|---|---|
|
Change From Baseline in the EQ-5D-5L Visual Analog Scale (VAS) Score at Weeks 4, 16, 28, 40 and 48
Week 4
|
9.03 score on a scale
Standard Error 2.07
|
|
Change From Baseline in the EQ-5D-5L Visual Analog Scale (VAS) Score at Weeks 4, 16, 28, 40 and 48
Week 16
|
9.26 score on a scale
Standard Error 2.30
|
|
Change From Baseline in the EQ-5D-5L Visual Analog Scale (VAS) Score at Weeks 4, 16, 28, 40 and 48
Week 28
|
6.99 score on a scale
Standard Error 2.39
|
|
Change From Baseline in the EQ-5D-5L Visual Analog Scale (VAS) Score at Weeks 4, 16, 28, 40 and 48
Week 40
|
8.61 score on a scale
Standard Error 2.11
|
|
Change From Baseline in the EQ-5D-5L Visual Analog Scale (VAS) Score at Weeks 4, 16, 28, 40 and 48
Week 48
|
6.90 score on a scale
Standard Error 2.31
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 4, 16, 28, 40, 48Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluable for each specified category.
The WPAI:GH2.0 is a patient self-rated clinical outcome assessment designed to provide a quantitative measure of the work productivity and activity impairment due to a health condition. The WPAI:GH2.0 assesses activities over the preceding 7 days and consists of 6 items: 1 item assesses employment (yes/no); 3 items assess the number of hours worked, the number of hours missed from work due to the participant's condition, or due to other reasons; and 2 visual numerical scales assess how much the participant's condition affects his/her productivity at work and his/her ability to complete normal daily activities. Each item (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) was calculated into an impairment percentage ranging from 0 to 100%, with higher numbers indicating greater impairment and less productivity (i.e. worse outcomes). Change from baseline for each item is shown here.
Outcome measures
| Measure |
Eptinezumab
n=95 Participants
Participants received 4 IV infusions of 400 mg eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
|
|---|---|
|
Change From Baseline in the Work Productivity Activity Impairment: General Health Second Version (WPAI:GH2.0) Sub-Scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Weeks 4, 16, 28, 40 and 48
Absenteeism - Week 4
|
-12.03 score on a scale
Standard Deviation 2.82
|
|
Change From Baseline in the Work Productivity Activity Impairment: General Health Second Version (WPAI:GH2.0) Sub-Scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Weeks 4, 16, 28, 40 and 48
Absenteeism - Week 16
|
-8.19 score on a scale
Standard Deviation 2.98
|
|
Change From Baseline in the Work Productivity Activity Impairment: General Health Second Version (WPAI:GH2.0) Sub-Scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Weeks 4, 16, 28, 40 and 48
Absenteeism - Week 28
|
-12.73 score on a scale
Standard Deviation 1.70
|
|
Change From Baseline in the Work Productivity Activity Impairment: General Health Second Version (WPAI:GH2.0) Sub-Scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Weeks 4, 16, 28, 40 and 48
Absenteeism - Week 40
|
-12.05 score on a scale
Standard Deviation 2.29
|
|
Change From Baseline in the Work Productivity Activity Impairment: General Health Second Version (WPAI:GH2.0) Sub-Scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Weeks 4, 16, 28, 40 and 48
Absenteeism - Week 48
|
-5.30 score on a scale
Standard Deviation 2.99
|
|
Change From Baseline in the Work Productivity Activity Impairment: General Health Second Version (WPAI:GH2.0) Sub-Scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Weeks 4, 16, 28, 40 and 48
Presenteeism - Week 4
|
-14.29 score on a scale
Standard Deviation 3.23
|
|
Change From Baseline in the Work Productivity Activity Impairment: General Health Second Version (WPAI:GH2.0) Sub-Scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Weeks 4, 16, 28, 40 and 48
Presenteeism - Week 16
|
-14.54 score on a scale
Standard Deviation 3.74
|
|
Change From Baseline in the Work Productivity Activity Impairment: General Health Second Version (WPAI:GH2.0) Sub-Scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Weeks 4, 16, 28, 40 and 48
Presenteeism - Week 28
|
-11.86 score on a scale
Standard Deviation 3.78
|
|
Change From Baseline in the Work Productivity Activity Impairment: General Health Second Version (WPAI:GH2.0) Sub-Scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Weeks 4, 16, 28, 40 and 48
Presenteeism - Week 40
|
-9.88 score on a scale
Standard Deviation 3.58
|
|
Change From Baseline in the Work Productivity Activity Impairment: General Health Second Version (WPAI:GH2.0) Sub-Scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Weeks 4, 16, 28, 40 and 48
Presenteeism - Week 48
|
-12.70 score on a scale
Standard Deviation 3.53
|
|
Change From Baseline in the Work Productivity Activity Impairment: General Health Second Version (WPAI:GH2.0) Sub-Scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Weeks 4, 16, 28, 40 and 48
Work productivity loss - Week 4
|
-17.28 score on a scale
Standard Deviation 3.34
|
|
Change From Baseline in the Work Productivity Activity Impairment: General Health Second Version (WPAI:GH2.0) Sub-Scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Weeks 4, 16, 28, 40 and 48
Work productivity loss - Week 16
|
-16.53 score on a scale
Standard Deviation 3.98
|
|
Change From Baseline in the Work Productivity Activity Impairment: General Health Second Version (WPAI:GH2.0) Sub-Scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Weeks 4, 16, 28, 40 and 48
Work productivity loss - Week 28
|
-14.60 score on a scale
Standard Deviation 3.96
|
|
Change From Baseline in the Work Productivity Activity Impairment: General Health Second Version (WPAI:GH2.0) Sub-Scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Weeks 4, 16, 28, 40 and 48
Work productivity loss - Week 40
|
-12.50 score on a scale
Standard Deviation 3.78
|
|
Change From Baseline in the Work Productivity Activity Impairment: General Health Second Version (WPAI:GH2.0) Sub-Scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Weeks 4, 16, 28, 40 and 48
Work productivity loss - Week 48
|
-12.16 score on a scale
Standard Deviation 3.77
|
|
Change From Baseline in the Work Productivity Activity Impairment: General Health Second Version (WPAI:GH2.0) Sub-Scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Weeks 4, 16, 28, 40 and 48
Activity impairment - Week 4
|
-15.99 score on a scale
Standard Deviation 2.56
|
|
Change From Baseline in the Work Productivity Activity Impairment: General Health Second Version (WPAI:GH2.0) Sub-Scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Weeks 4, 16, 28, 40 and 48
Activity impairment - Week 16
|
-15.64 score on a scale
Standard Deviation 2.84
|
|
Change From Baseline in the Work Productivity Activity Impairment: General Health Second Version (WPAI:GH2.0) Sub-Scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Weeks 4, 16, 28, 40 and 48
Activity impairment - Week 28
|
-17.37 score on a scale
Standard Deviation 2.74
|
|
Change From Baseline in the Work Productivity Activity Impairment: General Health Second Version (WPAI:GH2.0) Sub-Scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Weeks 4, 16, 28, 40 and 48
Activity impairment - Week 40
|
-18.73 score on a scale
Standard Deviation 2.79
|
|
Change From Baseline in the Work Productivity Activity Impairment: General Health Second Version (WPAI:GH2.0) Sub-Scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Weeks 4, 16, 28, 40 and 48
Activity impairment - Week 48
|
-14.35 score on a scale
Standard Deviation 2.95
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 4, 16, 28, 40, 48Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluable for each specified category.
Number of participants who visited a family doctor/general practitioner has been reported.
Outcome measures
| Measure |
Eptinezumab
n=112 Participants
Participants received 4 IV infusions of 400 mg eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
|
|---|---|
|
Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner
Week 0 - 0 visits
|
81 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner
Week 0 - 1 visit
|
18 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner
Week 0 - 2 visits
|
10 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner
Week 0 - 3 visits
|
1 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner
Week 0 - 4 visits
|
2 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner
Week 4 - 0 visits
|
82 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner
Week 4 - 1 visit
|
17 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner
Week 4 - 2 visits
|
5 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner
Week 4 - 3 visits
|
1 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner
Week 16 - 0 visits
|
80 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner
Week 16 - 1 visit
|
15 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner
Week 16 - 2 visits
|
2 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner
Week 16 - 3 visits
|
2 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner
Week 16 - 4 visits
|
1 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner
Week 16 - 5 visits
|
1 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner
Week 28 - 0 visits
|
76 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner
Week 28 - 1 visit
|
14 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner
Week 28 - 2 visits
|
6 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner
Week 28 - 3 visits
|
4 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner
Week 40 - 0 visits
|
67 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner
Week 40 - 1 visit
|
13 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner
Week 40 - 2 visits
|
8 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner
Week 40 - 3 visits
|
1 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner
Week 40 - 6 visits
|
2 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner
Week 48 - 0 visits
|
78 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner
Week 48 - 1 visit
|
9 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner
Week 48 - 2 visits
|
5 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner
Week 48 - 3 visits
|
1 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner
Week 48 - 6 visits
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 4, 16, 28, 40, 48Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluable for each specified category.
Number of participants who visited a specialist has been reported.
Outcome measures
| Measure |
Eptinezumab
n=112 Participants
Participants received 4 IV infusions of 400 mg eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
|
|---|---|
|
Health Care Resource Utilization - Number of Visits to a Specialist
Week 0 - 0 visits
|
51 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Specialist
Week 0 - 1 visit
|
40 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Specialist
Week 0 - 2 visits
|
18 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Specialist
Week 0 - 3 visits
|
2 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Specialist
Week 0 - 6 visits
|
1 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Specialist
Week 4 - 0 visits
|
74 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Specialist
Week 4 - 1 visit
|
28 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Specialist
Week 4 - 2 visits
|
1 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Specialist
Week 4 - 3 visits
|
1 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Specialist
Week 4 - 4 visits
|
1 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Specialist
Week 16 - 0 visits
|
64 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Specialist
Week 16 - 1 visit
|
23 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Specialist
Week 16 - 2 visits
|
9 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Specialist
Week 16 - 3 visits
|
2 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Specialist
Week 16 - 4 visits
|
1 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Specialist
Week 16 - 5 visits
|
1 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Specialist
Week 16 - 7 visits
|
1 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Specialist
Week 28 - 0 visits
|
68 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Specialist
Week 28 - 1 visit
|
25 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Specialist
Week 28 - 2 visits
|
4 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Specialist
Week 28 - 4 visits
|
2 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Specialist
Week 28 - 5 visits
|
1 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Specialist
Week 40 - 0 visits
|
62 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Specialist
Week 40 - 1 visit
|
22 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Specialist
Week 40 - 2 visits
|
4 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Specialist
Week 40 - 3 visits
|
1 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Specialist
Week 40 - 4 visits
|
1 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Specialist
Week 40 - 6 visits
|
1 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Specialist
Week 48 - 0 visits
|
72 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Specialist
Week 48 - 1 visit
|
17 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Specialist
Week 48 - 2 visits
|
3 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Specialist
Week 48 - 3 visits
|
1 Participants
|
|
Health Care Resource Utilization - Number of Visits to a Specialist
Week 48 - 6 visits
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 4, 16, 28, 40, 48Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluable for each specified category.
Number of participants who visited an emergency department due to CH has been reported.
Outcome measures
| Measure |
Eptinezumab
n=112 Participants
Participants received 4 IV infusions of 400 mg eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
|
|---|---|
|
Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache
Week 0 - 0 visits
|
108 Participants
|
|
Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache
Week 0 - 1 visit
|
1 Participants
|
|
Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache
Week 0 - 2 visits
|
1 Participants
|
|
Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache
Week 0 - 4 visits
|
2 Participants
|
|
Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache
Week 4 - 0 visits
|
102 Participants
|
|
Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache
Week 4 - 1 visit
|
2 Participants
|
|
Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache
Week 4 - 4 visits
|
1 Participants
|
|
Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache
Week 16 - 0 visits
|
97 Participants
|
|
Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache
Week 16 - 1 visit
|
2 Participants
|
|
Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache
Week 16 - 2 visits
|
1 Participants
|
|
Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache
Week 16 - 4 visits
|
1 Participants
|
|
Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache
Week 28 - 0 visits
|
96 Participants
|
|
Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache
Week 28 - 1 visit
|
2 Participants
|
|
Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache
Week 28 - 2 visits
|
1 Participants
|
|
Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache
Week 28 - 4 visits
|
1 Participants
|
|
Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache
Week 40 - 0 visits
|
88 Participants
|
|
Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache
Week 40 - 1 visit
|
1 Participants
|
|
Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache
Week 40 - 2 visits
|
2 Participants
|
|
Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache
Week 48 - 0 visits
|
91 Participants
|
|
Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache
Week 48 - 1 visit
|
1 Participants
|
|
Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache
Week 48 - 2 visits
|
1 Participants
|
|
Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache
Week 48 - 3 visits
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 4, 16, 28, 40, 48Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluable for each specified category.
Number of participants admitted to the hospital due to CH has been reported.
Outcome measures
| Measure |
Eptinezumab
n=112 Participants
Participants received 4 IV infusions of 400 mg eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
|
|---|---|
|
Health Care Resource Utilization - Number of Hospital Admissions Due to Cluster Headache
Week 0 - 0 admissions
|
110 Participants
|
|
Health Care Resource Utilization - Number of Hospital Admissions Due to Cluster Headache
Week 0 - 1 admission
|
2 Participants
|
|
Health Care Resource Utilization - Number of Hospital Admissions Due to Cluster Headache
Week 4 - 0 admissions
|
103 Participants
|
|
Health Care Resource Utilization - Number of Hospital Admissions Due to Cluster Headache
Week 4 - 1 admission
|
2 Participants
|
|
Health Care Resource Utilization - Number of Hospital Admissions Due to Cluster Headache
Week 16 - 0 admissions
|
98 Participants
|
|
Health Care Resource Utilization - Number of Hospital Admissions Due to Cluster Headache
Week 16 - 1 admission
|
2 Participants
|
|
Health Care Resource Utilization - Number of Hospital Admissions Due to Cluster Headache
Week 16 - 5 admissions
|
1 Participants
|
|
Health Care Resource Utilization - Number of Hospital Admissions Due to Cluster Headache
Week 28 - 0 admissions
|
97 Participants
|
|
Health Care Resource Utilization - Number of Hospital Admissions Due to Cluster Headache
Week 28 - 1 admission
|
3 Participants
|
|
Health Care Resource Utilization - Number of Hospital Admissions Due to Cluster Headache
Week 40 - 0 admissions
|
89 Participants
|
|
Health Care Resource Utilization - Number of Hospital Admissions Due to Cluster Headache
Week 40 - 1 admission
|
1 Participants
|
|
Health Care Resource Utilization - Number of Hospital Admissions Due to Cluster Headache
Week 40 - 5 admissions
|
1 Participants
|
|
Health Care Resource Utilization - Number of Hospital Admissions Due to Cluster Headache
Week 48 - 0 admissions
|
92 Participants
|
|
Health Care Resource Utilization - Number of Hospital Admissions Due to Cluster Headache
Week 48 - 1 admission
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Weeks 4, 16, 28, 40, 48Population: The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure, and "Number analyzed" is the number of participants evaluable for each specified category.
Number of participants who had overnight hospital stays due to CH has been reported.
Outcome measures
| Measure |
Eptinezumab
n=112 Participants
Participants received 4 IV infusions of 400 mg eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
|
|---|---|
|
Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache
Week 0 - 0 visits
|
109 Participants
|
|
Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache
Week 0 - 1 visit
|
2 Participants
|
|
Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache
Week 0 - 2 visits
|
1 Participants
|
|
Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache
Week 4 - 0 visits
|
105 Participants
|
|
Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache
Week 16 - 0 visits
|
98 Participants
|
|
Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache
Week 16 - 1 visit
|
1 Participants
|
|
Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache
Week 16 - 7 visits
|
1 Participants
|
|
Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache
Week 16 - 10 visits
|
1 Participants
|
|
Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache
Week 28 - 0 visits
|
99 Participants
|
|
Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache
Week 28 - 1 visit
|
1 Participants
|
|
Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache
Week 40 - 0 visits
|
90 Participants
|
|
Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache
Week 40 - 1 visit
|
1 Participants
|
|
Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache
Week 48 - 0 visits
|
92 Participants
|
|
Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache
Week 48 - 1 visit
|
1 Participants
|
|
Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache
Week 48 - 5 visits
|
1 Participants
|
Adverse Events
Eptinezumab
Serious events: 11 serious events
Other events: 96 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Eptinezumab
n=131 participants at risk
Participants received 4 IV infusions of 400 mg eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
|
|---|---|
|
Endocrine disorders
Thyroiditis acute
|
0.76%
1/131 • Number of events 1 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.76%
1/131 • Number of events 1 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.76%
1/131 • Number of events 1 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
General disorders
Fatigue
|
0.76%
1/131 • Number of events 1 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.76%
1/131 • Number of events 1 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.76%
1/131 • Number of events 1 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Investigations
Weight decreased
|
0.76%
1/131 • Number of events 1 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.76%
1/131 • Number of events 1 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.76%
1/131 • Number of events 1 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Nervous system disorders
Cluster headache
|
0.76%
1/131 • Number of events 7 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Psychiatric disorders
Suicide attempt
|
0.76%
1/131 • Number of events 1 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.76%
1/131 • Number of events 1 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
Other adverse events
| Measure |
Eptinezumab
n=131 participants at risk
Participants received 4 IV infusions of 400 mg eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
|
|---|---|
|
Cardiac disorders
Atrioventricular block first degree
|
2.3%
3/131 • Number of events 5 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Ear and labyrinth disorders
Tinnitus
|
3.1%
4/131 • Number of events 4 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.1%
4/131 • Number of events 6 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Gastrointestinal disorders
Constipation
|
4.6%
6/131 • Number of events 9 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Gastrointestinal disorders
Nausea
|
6.1%
8/131 • Number of events 8 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
7/131 • Number of events 7 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
General disorders
Asthenia
|
4.6%
6/131 • Number of events 11 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
General disorders
Fatigue
|
16.8%
22/131 • Number of events 30 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
General disorders
Influenza like illness
|
2.3%
3/131 • Number of events 4 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
General disorders
Oedema peripheral
|
3.8%
5/131 • Number of events 7 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Infections and infestations
Bronchitis
|
2.3%
3/131 • Number of events 3 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Infections and infestations
COVID-19
|
22.1%
29/131 • Number of events 31 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Infections and infestations
Gastroenteritis
|
2.3%
3/131 • Number of events 3 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Infections and infestations
Influenza
|
7.6%
10/131 • Number of events 10 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Infections and infestations
Nasopharyngitis
|
18.3%
24/131 • Number of events 33 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Infections and infestations
Pharyngitis
|
3.8%
5/131 • Number of events 5 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Infections and infestations
Pneumonia
|
2.3%
3/131 • Number of events 4 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Infections and infestations
Rhinitis
|
4.6%
6/131 • Number of events 6 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Infections and infestations
Sinusitis
|
2.3%
3/131 • Number of events 3 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Infections and infestations
Urinary tract infection
|
3.1%
4/131 • Number of events 5 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Injury, poisoning and procedural complications
Fall
|
3.1%
4/131 • Number of events 5 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
2.3%
3/131 • Number of events 3 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Investigations
Blood creatine phosphokinase increased
|
2.3%
3/131 • Number of events 4 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Investigations
Blood triglycerides increased
|
2.3%
3/131 • Number of events 3 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Investigations
Weight increased
|
6.1%
8/131 • Number of events 8 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
4.6%
6/131 • Number of events 6 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.3%
3/131 • Number of events 5 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.9%
9/131 • Number of events 9 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.3%
3/131 • Number of events 5 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Nervous system disorders
Dizziness
|
5.3%
7/131 • Number of events 7 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Psychiatric disorders
Insomnia
|
6.1%
8/131 • Number of events 9 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Psychiatric disorders
Nightmare
|
2.3%
3/131 • Number of events 3 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Psychiatric disorders
Sleep disorder
|
2.3%
3/131 • Number of events 3 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Psychiatric disorders
Suicidal ideation
|
2.3%
3/131 • Number of events 3 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.1%
4/131 • Number of events 4 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.3%
3/131 • Number of events 3 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.1%
4/131 • Number of events 4 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.9%
9/131 • Number of events 9 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Vascular disorders
Hypertension
|
3.1%
4/131 • Number of events 4 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
|
Vascular disorders
Orthostatic hypotension
|
2.3%
3/131 • Number of events 3 • From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
The APTS included all participants who received infusion with eptinezumab
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place