A Single Center, Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Fremanezumab (675 mg Quarterly) in Female Patients Aged 18-45 With Menstrual Migraine
Overview
- Phase
- Phase 4
- Intervention
- Fremanezumab
- Conditions
- Migraine
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Migraine Days
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
Brief Summary
The goal of this clinical trial is to learn about how a migraine prevention medicine works for people who have migraines/headaches with their menstrual period. The study includes people ages 18 to 45 who have been diagnosed with migraine and who have a migraine with their menstrual period or those who have migraines with their menstrual period and at other times of the month as well.
The main question the study aims to answer are:
• Does fremanazemab, an injectable calcitonin gene-related peptide (CGRP) pathway targeting therapy, decrease migraines associated with menstruation?
Participants will
- have an evaluation and examination by a headache specialist physician
- will receive the study medicine or inactive substitute every three months for two treatments
- fill out diaries about their migraines
- have tests on saliva to measure hormone levels
Researchers will compare the people who get the medicine to those who get the inactive substitute to see if there are differences in response.
Detailed Description
Patients who meet the eligibility criteria and wish to participate will be consented, and will then be randomized to receive two rounds of treatment with either fremanezumab or placebo, administered 3 months apart, to understand efficacy and response in decreasing migraine days. The investigators will monitor with daily logs and use evidenced metrics to assess response. Participants will be carefully screened to ensure that they do not become pregnant while in the study. The investigators will measure monthly hormone levels using salivary samples. Each participant will have three in-person visits and will have five 5 visits via secure telehealth. The investigators are studying decreased headache days, severity, disability and quality of life.
Investigators
Carolyn A. Bernstein
Principal Investigator
Brigham and Women's Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients may be randomized in this study only if they meet all of the following criteria:
- •The patient is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in this protocol
- •The patient is female aged 18 to 45 years of age, inclusive
- •The patient has a diagnosis of pure menstrual migraine (MM) or menstrual-related migraine (MRM)
- •Prior to the screening visit (V1) the patient has a 6 month history of either:
- •Menstrual Migraine (MM)
- •Headache consistent with Menstrual Migraine (MM)
- •Menstrually-Related Migraine (MRM)
- •The patient fulfils the following criteria for migraine in a prospectively collected diary during the 28-day baseline period:
- •○ Migraine attacks starting in the peri-menstrual period (days -2 to +3 of menstruation)
Exclusion Criteria
- •Patients will not be randomized/enrolled in this study if they meet any of the following criteria:
- •The patient uses medications containing opioids or barbiturates on more than 4 days during the 28-day baseline period for the treatment of migraine or any other reason
- •The patient uses \>8 rimegepant or ubrogepant tablets per month
- •The patient has ≥15 headache days per month
- •The patient has used am intervention/device (eg, scheduled nerve blocks, implantable vagal nerve stimulation, and transcranial magnetic stimulation) for migraine during the 2 months prior to screening
- •The patient is overusing acute medication
- •The patient is pregnant or lactating or planning to get pregnant in ≤13 months post screening visit (V1)
- •The patient has clinically significant hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic or ocular disease, at the discretion of the sponsor
- •The patient has a history of clinically significant cardiovascular disease or vascular ischemia (such as myocardial, neurological \[eg, cerebral ischemia\], peripheral extremity ischemia, or other ischemic event) or thromboembolic events (arterial or venous thrombotic or embolic events), such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism
- •The patient has a known infection or history of human immunodeficiency virus, tuberculosis, any history of Lyme disease, or chronic hepatitis B or C infection
Arms & Interventions
Patients receiving active medication
These patients will receive 675 mg of fremanezumab for two total doses administered 3 months apart.
Intervention: Fremanezumab
Patients receiving placebo
These patients will receive placebo injections for two total doses administered 3 months apart.
Intervention: Placebo
Outcomes
Primary Outcomes
Migraine Days
Time Frame: 6 months
The number of active migraine days during the 24-week treatment period after the 1st dose of study drug.
Secondary Outcomes
- Migraine Duration(6 months)
- Responder Status(6 months)
- Rescue Medication Use(6 months)
- Migraine Severity(6 months)
- Migraine Specific Quality of Life Measure(6 months)
- Disability (MIDAS)(6 months)
- Anxiety (GAD-7)(6 months)
- Sleep Quality (PSQI)(6 months)
- Disability (HIT-6)(6 months)
- Depression (PHQ-9)(6 months)
- Hormone Levels(6 months)