Trial Outcomes & Findings for Fremanezumab, Migraine and Sleep (NCT NCT04693533)
NCT ID: NCT04693533
Last Updated: 2026-02-27
Results Overview
This primary outcome measures improvement in sleep quality during the treatment period as compared to the pre-treatment period. Sleep quality will be measured using the Insomnia Severity Index. This index scores requires subjects to answer 7 questions by depicting a number (between 0 and 4 ) that represents best their answer. The scale of the Insomnia Severity Index is 0-28. The total score categories are as follows: 0-7 = No clinically significant insomnia, 8-14 = Subthreshold insomnia, 15-21 = Clinical insomnia (moderate severity), 22-28 = Clinical insomnia (severe).
TERMINATED
PHASE4
22 participants
1 month before and 3 month after treatment
2026-02-27
Participant Flow
Study terminated due to inability to recruit patients that met the sleep disorder criteria.
Participant milestones
| Measure |
Treatment Effect
Open label , no placebo or control
Fremanezumab Prefilled Syringe \[Ajovy\]: The treatment is 225 mg (dissolved in 1.5 ml saline) fremanezumab. Fremanezumab (Ajovy) is a month-long-acting anti-CGRP injection that patients are taught to self-administer at home.
|
|---|---|
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Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fremanezumab, Migraine and Sleep
Baseline characteristics by cohort
| Measure |
Treatment Effect
n=22 Participants
Open label , no placebo or control
Fremanezumab Prefilled Syringe \[Ajovy\]: The treatment is 225 mg (dissolved in 1.5 ml saline) fremanezumab. Fremanezumab (Ajovy) is a month-long-acting anti-CGRP injection that patients are taught to self-administer at home.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
white
|
19 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
native Hawaiian or other Pacific Islander
|
0 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan native
|
0 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
multiracial
|
0 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
unknown
|
0 Participants
n=24 Participants
|
|
Race/Ethnicity, Customized
other
|
2 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 1 month before and 3 month after treatmentThis primary outcome measures improvement in sleep quality during the treatment period as compared to the pre-treatment period. Sleep quality will be measured using the Insomnia Severity Index. This index scores requires subjects to answer 7 questions by depicting a number (between 0 and 4 ) that represents best their answer. The scale of the Insomnia Severity Index is 0-28. The total score categories are as follows: 0-7 = No clinically significant insomnia, 8-14 = Subthreshold insomnia, 15-21 = Clinical insomnia (moderate severity), 22-28 = Clinical insomnia (severe).
Outcome measures
| Measure |
1 Month Prior to Treatment
n=22 Participants
Participants self-reported sleep quality as measured by the Insomnia Severity Index
|
3 Months After Treatment
n=22 Participants
Participants self-reported sleep quality as measured by the Insomnia Severity Index
|
|---|---|---|
|
Fremanezumab and Sleep
0-7 = No clinically significant insomnia
|
22 participants
|
22 participants
|
|
Fremanezumab and Sleep
8-14 = Subthreshold insomnia
|
0 participants
|
0 participants
|
|
Fremanezumab and Sleep
15-21 = Clinical insomnia (moderate severity)
|
0 participants
|
0 participants
|
|
Fremanezumab and Sleep
22-28 = Clinical insomnia (severe)
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 1 month before and 3 month after treatmentThis primary outcome measures changes in number of migraine days per month before and during treatment. The number of migraine days per month will be captures using a validated headache questionnaire and scores as follows: 0-8 migraine days per month = low frequency episodic migraine, 9-14 migraine days per month = high frequency episodic migraine, 15-30 migraine days per month = chronic migraine.
Outcome measures
| Measure |
1 Month Prior to Treatment
n=22 Participants
Participants self-reported sleep quality as measured by the Insomnia Severity Index
|
3 Months After Treatment
n=22 Participants
Participants self-reported sleep quality as measured by the Insomnia Severity Index
|
|---|---|---|
|
Fremanezumab and Migraine
0-8 migraine days per month = low frequency episodic migraine
|
1 participants
|
15 participants
|
|
Fremanezumab and Migraine
9-14 migraine days per month = high frequency episodic migraine
|
5 participants
|
5 participants
|
|
Fremanezumab and Migraine
15-30 migraine days per month = chronic migraine.
|
16 participants
|
2 participants
|
Adverse Events
Treatment Effect
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place