Migraine DisordersPhase 4NCT04693533
Fremanezumab, Migraine and Sleep
A Phase 4 study testing Fremanezumab Prefilled Syringe [Ajovy] in people with Migraine Disorders and Sleep Disorder, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Disorders, Sleep Disorder
- What is being tested?
- Fremanezumab Prefilled Syringe [Ajovy]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2021to 1 Apr 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 18 and 65 years
- Been previously diagnosed with migraine (with or without aura), in accordance with the ICHD-3 criteria
- Experiences between 10 to 25 headaches days per month (during the last 3 months), with at least 8 of them being migraine days during which the migraines lasted more than 4 hours if untreated
- Onset of migraine at age 50 years or younger
- Agrees to refrain from initiating or changing the type, dosage, or frequency of any prophylactic medications for indications other than migraine that may interfere with the study objectives (e.g., antidepressants, anticonvulsants, beta-adrenergic blockers, etc.)
- Able to provide written informed consent
- Scoring 10 or higher on the Insomnia Severity Index (8-14 = subthreshold insomnia, 15-21 = clinical insomnia of moderate severity, 22-28 = clinical insomnia of severe severity)
Who cannot join
- -
- Currently on a regimen of 1 or more migraine preventative therapy
- Other significant pain problem (e.g., cancer pain, fibromyalgia, other head or facial pain disorder) that may confound the study assessments
- Known or suspected severe cardiac disease (e.g., symptomatic coronary artery disease, prior myocardial infarction, congestive heart failure)
- Known or suspected cerebrovascular disease (e.g., prior stroke or transient ischemic attack, symptomatic carotid artery disease, prior carotid endarterectomy or other vascular neck surgery)
- Abnormal baseline electrocardiogram (ECG) within the last year (e.g., second or third-degree heart block, prolonged QT interval, atrial fibrillation, atrial flutter, history of ventricular tachycardia or ventricular fibrillation, clinically significant premature ventricular contraction)
Show all 23Show fewer
- Uncontrolled high blood pressure (systolic >160 mm HG, diastolic >100 mm Hg) after 3 measurements within 24 hours
- Known history or suspicion of secondary headache
- Known history or suspicion of substance abuse or addiction (within the last 5 years)
- Currently using marijuana (including medical marijuana) or has used marijuana (including medical marijuana) or cannabidiol oil within the last 1 year
- Currently takes simple analgesics or NSAIDs >15 days per month or triptans, ergots, or combined analgesics >10 days per month for headaches or other body pain
- Currently takes prescription opioids for headaches or body pain
- Undergone nerve block (occipital or other) in the head or neck within the last 3 months
- Received botulinum toxin or anti-CGRP-mAb injections within the last 6 months
- Nursing, pregnant or thinking of becoming pregnant during the study period, or of childbearing years and unwilling to use an accepted form of birth control
- Participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days
- Belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with the follow-up requirements, or provide self-assessments is compromised.
- A relative of or an employee of the Investigator or the clinical study site
- Psychiatric or cognitive disorder and/or behavioral problems that, in the opinion of the clinician, may interfere with the study
- History of claustrophobia
- Diagnosis of obstructive sleep apnea or restless legs syndrome
- BMI of 30 or greater
- Daily use of sleep-promoting drugs. These include eszopiclone; zaleplon; zolpidem; benzodiazepines (estazolam, flurazepam, quazepam, temazepam, triazolam); barbiturates (amobarbital, amobarbital-secobarbital, chloral hydrate); doxepin; quetiapine; ramelteon; trazodone; suvorexant; lemborexant; OTC nighttime meds (doxyalamine; diphenydrame); and melatonin.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Migraine Disorders, Sleep Disorder
- Being tested
- Fremanezumab Prefilled Syringe [Ajovy]
- Medical subject headings
- Migraine Disorders, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fremanezumab Prefilled Syringe [Ajovy]Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| treatment effect | Experimental | Open label , no placebo or control Receives: Drug: Fremanezumab Prefilled Syringe [Ajovy] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fremanezumab and Sleep
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).
Measured: 1 month before and 3 month after treatment
Fremanezumab and Migraine
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.
Measured: 1 month before and 3 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start29 Jul 2021
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Why it stopped: poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Responsible party
- Principal investigator, Rami Burstein, Beth Israel Deaconess Medical Center
- Investigators
- Sait Ashina, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04693533
- Sponsor's protocol ID
- 2020P-001191
- Status last verified
- Feb 2026
- First submitted
- 29 Dec 2020
- Last updated
- 27 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fremanezumab, Migraine and Sleep
- ClinicalTrials.gov ID
- NCT04693533
- Acronym / sponsor ID
- 2020P-001191
- Conditions
- Migraine Disorders, Sleep Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor enrollment
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Study start
- 29 Jul 2021 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Posted 27 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment effect | Experimental | Drug: Fremanezumab Prefilled Syringe [Ajovy]Open label , no placebo or control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Between the ages of 18 and 65 years
- Been previously diagnosed with migraine (with or without aura), in accordance with the ICHD-3 criteria
- Experiences between 10 to 25 headaches days per month (during the last 3 months), with at least 8 of them being migraine days during which the migraines lasted more than 4 hours if untreated
- Onset of migraine at age 50 years or younger
- Agrees to refrain from initiating or changing the type, dosage, or frequency of any prophylactic medications for indications other than migraine that may interfere with the study objectives (e.g., antidepressants, anticonvulsants, beta-adrenergic blockers, etc.)
Key exclusion criteria (23 listed)
- -
- Currently on a regimen of 1 or more migraine preventative therapy
- Other significant pain problem (e.g., cancer pain, fibromyalgia, other head or facial pain disorder) that may confound the study assessments
- Known or suspected severe cardiac disease (e.g., symptomatic coronary artery disease, prior myocardial infarction, congestive heart failure)
- Known or suspected cerebrovascular disease (e.g., prior stroke or transient ischemic attack, symptomatic carotid artery disease, prior carotid endarterectomy or other vascular neck surgery)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | treatment effect |
Primary outcome
Fremanezumab and Sleep
Time frame: 1 month before and 3 month after treatment
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).
Fremanezumab and Migraine
Time frame: 1 month before and 3 month after treatment
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sait Ashina, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fremanezumab Prefilled Syringe [Ajovy] in people with Migraine Disorders and Sleep Disorder, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fremanezumab and Sleep (time frame: 1 month before and 3 month after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.