Fremanezumab, Migraine and Sleep

NCT04693533 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 2020P-001191
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Migraine Disorders; Sleep Disorder

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  1 month before and 3 month after treatment

Study Arms (1)

treatment effect

EXPERIMENTAL

Open label , no placebo or control

Drug: Fremanezumab Prefilled Syringe [Ajovy]

Interventions

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.

treatment effect

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Teva Pharmaceuticals USA: collaborator

Study Sites (1)

BIDMC Headaceh Clinic

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Sleep Wake Disorders

Interventions

erenumab

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Results Point of Contact

• Title: Rami Burstein, professor
• Organization: BIDMC

rburstei@bidmc.harvard.edu

617 735 2832

Study Officials

• Sait Ashina, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesia

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: January 5, 2021
• Study Start: July 29, 2021
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: February 27, 2026
• Results First Posted: February 27, 2026

Record last verified: 2026-02

Locations

US (1)