Trial Outcomes & Findings for A Study of LY2951742 (Galcanezumab) in Participants With Cluster Headache (NCT NCT02797951)
NCT ID: NCT02797951
Last Updated: 2022-02-10
Results Overview
A TEAE is defined as the reported AEs that first occurred or worsened during the post-baseline phase compared with the baseline phase. An SAE is any adverse event from this study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. A summary of serious and other non-serious adverse events regardless of causality is located in the reported adverse events module.
COMPLETED
PHASE3
165 participants
Baseline through End of Study (Up to 4 Years)
2022-02-10
Participant Flow
Participants who completed one of the parent studies I5Q-MC-CGAL (NCT02397473) or I5Q-MC-CGAM (NCT02438826) were enrolled in this study.
Participant milestones
| Measure |
Galcanezumab 300 mg SC
Participants received 300 milligram (mg) Galcanezumab administered subcutaneously (SC) up to once a month.
|
|---|---|
|
Overall Study
STARTED
|
165
|
|
Overall Study
Received at Least One Dose of Study Drug
|
164
|
|
Overall Study
COMPLETED
|
116
|
|
Overall Study
NOT COMPLETED
|
49
|
Reasons for withdrawal
| Measure |
Galcanezumab 300 mg SC
Participants received 300 milligram (mg) Galcanezumab administered subcutaneously (SC) up to once a month.
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Death
|
1
|
|
Overall Study
Lack of Efficacy
|
19
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Physician Decision
|
6
|
|
Overall Study
Withdrawal by Subject
|
15
|
Baseline Characteristics
A Study of LY2951742 (Galcanezumab) in Participants With Cluster Headache
Baseline characteristics by cohort
| Measure |
Galcanezumab 300 mg SC
n=164 Participants
Participants received 300 mg Galcanezumab administered SC up to once a month.
|
|---|---|
|
Age, Continuous
|
48.30 years
STANDARD_DEVIATION 9.76 • n=39 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
123 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
117 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
25 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
140 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
19 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
Belgium
|
17 Participants
n=39 Participants
|
|
Region of Enrollment
Canada
|
7 Participants
n=39 Participants
|
|
Region of Enrollment
Denmark
|
4 Participants
n=39 Participants
|
|
Region of Enrollment
Finland
|
5 Participants
n=39 Participants
|
|
Region of Enrollment
France
|
23 Participants
n=39 Participants
|
|
Region of Enrollment
Germany
|
25 Participants
n=39 Participants
|
|
Region of Enrollment
Greece
|
2 Participants
n=39 Participants
|
|
Region of Enrollment
Italy
|
24 Participants
n=39 Participants
|
|
Region of Enrollment
Netherlands
|
8 Participants
n=39 Participants
|
|
Region of Enrollment
Spain
|
17 Participants
n=39 Participants
|
|
Region of Enrollment
United Kingdom
|
4 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
28 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Baseline through End of Study (Up to 4 Years)Population: All participants who received at least one dose of study drug.
A TEAE is defined as the reported AEs that first occurred or worsened during the post-baseline phase compared with the baseline phase. An SAE is any adverse event from this study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. A summary of serious and other non-serious adverse events regardless of causality is located in the reported adverse events module.
Outcome measures
| Measure |
Galcanezumab 300 mg SC
n=164 Participants
Participants received 300 mg Galcanezumab administered SC up to once a month.
|
|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs)
TEAEs
|
119 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs)
SAEs
|
17 Participants
|
PRIMARY outcome
Timeframe: Baseline through End of Study (Up to 4 Years)Population: All participants who received at least one dose of study drug and had at least one postbaseline C-SSRS assessment.
C-SSRS is a scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviours, and has a binary response (yes/no). * Suicidal Ideation: a "yes" answer to any one of 5 suicidal ideation questions: Wish to be Dead, Non-specific Active Suicidal Thoughts, Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act, Active Suicidal Ideation with Some Intent to Act, without Specific Plan, Active Suicidal Ideation with Specific Plan and Intent. * Suicidal Behaviour: a "yes" answer to any of 5 suicidal behaviour questions: Preparatory Acts or Behaviour, Aborted Attempt, Interrupted Attempt, Actual Attempt (non-fatal), Completed Suicide.
Outcome measures
| Measure |
Galcanezumab 300 mg SC
n=164 Participants
Participants received 300 mg Galcanezumab administered SC up to once a month.
|
|---|---|
|
Number of Participants With Suicidal Ideation and Behaviours Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)
Suicidal Ideation
|
2 Participants
|
|
Number of Participants With Suicidal Ideation and Behaviours Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)
Suicidal Behaviour
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline through End of Study (Up to 4 Years)Population: All participants who received at least one dose of study drug and had baseline and at least one post baseline ADA assessment.
A participant is considered TE-ADA positive if: * ADA "not present" baseline result and any subsequent "present" postbaseline ADA result with a titer of at least 1:20 (treatment-induced), or * ADA "present" baseline result and any subsequent "present" postbaseline ADA result with a 4-fold or greater increase in titer from baseline (treatment-boosted).
Outcome measures
| Measure |
Galcanezumab 300 mg SC
n=159 Participants
Participants received 300 mg Galcanezumab administered SC up to once a month.
|
|---|---|
|
Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) to Galcanezumab
|
8 Participants
|
Adverse Events
Galcanezumab 300 mg SC
Serious adverse events
| Measure |
Galcanezumab 300 mg SC
n=164 participants at risk
Participants received 300 mg Galcanezumab administered SC up to once a month.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
0.61%
1/164 • Number of events 1 • Baseline through End of Study (Up to 4 Years)
All participants who received at least one dose of study drug.
|
|
General disorders
Chest discomfort
|
0.61%
1/164 • Number of events 1 • Baseline through End of Study (Up to 4 Years)
All participants who received at least one dose of study drug.
|
|
Immune system disorders
Sarcoidosis
|
0.61%
1/164 • Number of events 1 • Baseline through End of Study (Up to 4 Years)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.61%
1/164 • Number of events 1 • Baseline through End of Study (Up to 4 Years)
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.61%
1/164 • Number of events 1 • Baseline through End of Study (Up to 4 Years)
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Exposure to household chemicals
|
0.61%
1/164 • Number of events 1 • Baseline through End of Study (Up to 4 Years)
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.61%
1/164 • Number of events 1 • Baseline through End of Study (Up to 4 Years)
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.61%
1/164 • Number of events 1 • Baseline through End of Study (Up to 4 Years)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.61%
1/164 • Number of events 1 • Baseline through End of Study (Up to 4 Years)
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.61%
1/164 • Number of events 1 • Baseline through End of Study (Up to 4 Years)
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.61%
1/164 • Number of events 1 • Baseline through End of Study (Up to 4 Years)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cluster headache
|
1.8%
3/164 • Number of events 3 • Baseline through End of Study (Up to 4 Years)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Sciatica
|
0.61%
1/164 • Number of events 1 • Baseline through End of Study (Up to 4 Years)
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Completed suicide
|
0.61%
1/164 • Number of events 1 • Baseline through End of Study (Up to 4 Years)
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.61%
1/164 • Number of events 1 • Baseline through End of Study (Up to 4 Years)
All participants who received at least one dose of study drug.
|
|
Vascular disorders
Arterial occlusive disease
|
0.61%
1/164 • Number of events 1 • Baseline through End of Study (Up to 4 Years)
All participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Galcanezumab 300 mg SC
n=164 participants at risk
Participants received 300 mg Galcanezumab administered SC up to once a month.
|
|---|---|
|
Infections and infestations
Bronchitis
|
6.1%
10/164 • Number of events 16 • Baseline through End of Study (Up to 4 Years)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Influenza
|
9.8%
16/164 • Number of events 21 • Baseline through End of Study (Up to 4 Years)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
22.0%
36/164 • Number of events 46 • Baseline through End of Study (Up to 4 Years)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
11/164 • Number of events 14 • Baseline through End of Study (Up to 4 Years)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
11/164 • Number of events 13 • Baseline through End of Study (Up to 4 Years)
All participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60