Fremanezumab, Migraine and Sleep
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|ClinicalTrials.gov Identifier: NCT04693533|
Recruitment Status : Recruiting
First Posted : January 5, 2021
Last Update Posted : March 31, 2022
The main goal of this study is to determine whether there is a relationship between fremanezumab's ability to prevent migraine and improved sleep quality in migraine patients (fremanezumab is a FDA-approved humanized CGRP monoclonal antibody for the treatment of migraine).
This is a within-person study design that examines treatment effects (changes) using high-resolution assessments. To complete the study, each participant will be observed using daily assessments of migraine and sleep outcomes before treatment (baseline: 0 to 30 days), and at 1, 2, and 3 months after treatment (injection 1: days 31-60, injection 2: days 61-90, injection 3: days 91-120). In essence, this creates an interrupted time-series design where repeated interventions are introduced at fixed intervals.
|Condition or disease||Intervention/treatment||Phase|
|Migraine Disorders Sleep Disorder||Drug: Fremanezumab Prefilled Syringe [Ajovy]||Phase 4|
The study involves 5 visits to the headache clinic:
In clinic visit 1 (day 0), subjects will learn about the study and if they agree to participate, will be consented and screened for eligibility. Those deemed to be eligible will be asked to fill a headache questionnaire and then taught how to fill at home a daily e-diary for sleep and a daily e-diary for headache.
In clinic visit 2 (day 30), subjects will return to the headache clinic to review their e-diaries and receive the first treatment. The treatment is 225 mg (dissolved in 1.5 ml solution) fremanezumab. Fremanezumab is a monthly dosed anti-CGRP mAb injection.
In clinic visit 3 (day 60), we will review participants' headache and sleep diaries 1 month after receiving the 1st injection and administer the 2nd injection. This appointment will be conducted by either one of the study physicians or the study nurse.
In clinic visit 4 (day 90), we will review participants' headache and sleep diaries 1 month after receiving the 2nd injection and and administer the 3rd injection. This appointment will be conducted by either one of the study physicians or the study nurse.
In clinic visit 5 (day 120), participants will return to the headache clinic to summarize their experience, review their 120-days e-diaries, and provide any feedback they may have about their experience with fremanezumab.
Assessments of headache and sleep:
At screening (visit 1), headache severity and impact will be assessed based on patients' interviews and HIT-6. Sleep quality will be assessed using the Insomnia Severity Index. (https://cbtscience.files.wordpress.com/2014/02/insomniaseverityindex.pdf).
On days 30, 60, 90 and 120, baseline and treatment impact on headache and sleep will be assessed using the Headache e-diary and the consensus sleep diary [Carney et al., (2012) The consensus sleep diary: Standardizing prospective sleep self-monitoring, Sleep Vol.35, No.2, pp.287-302], the latter of which captures total sleep time, sleep latency, wake after sleep onset, number of awakenings, quality, sleep efficiency, and trouble staying awake.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fremanezumab, Migraine and Sleep|
|Actual Study Start Date :||July 29, 2021|
|Estimated Primary Completion Date :||July 30, 2022|
|Estimated Study Completion Date :||December 30, 2022|
No 2 arms and only 1 intervention
Drug: 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.
- Fremanezumab and sleep [ Time Frame: 4 months ]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 = Subthershold insomnia, 15-21 = Clinical insomnia (moderate severity), 22-28 = Clinical insomnia (severe).
- Fremanezumab and migraine [ Time Frame: 4 months ]This 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04693533
|Contact: Tolu ajayi||617 975 firstname.lastname@example.org|
|United States, Massachusetts|
|BIDMC Headaceh Clinic||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Sait Ashina, MD|
|Principal Investigator:||Sait Ashina, MD||Beth Israel Deaconess Medical Center|