Fremanezumab Treatment of Migraine in Women With Menstrual Migraine Ages 18-45 (NCT06173661) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Fremanezumab Treatment of Migraine in Women With Menstrual Migraine Ages 18-45
United States72 participantsStarted 2024-03-01
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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:
. The patient fulfils the following criteria for migraine in a prospectively collected diary during the 28-day baseline period:
. The patient agrees not to initiate any migraine preventive medications during the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. The patient is in good health in the opinion of the sponsor as determined by medical evaluation, including medical history, neurologic examination, laboratory tests and cardiac monitoring
. The patient has a body weight ≥45 kg and a body mass index within the range of 17.5 to 34.9 kg/m\^2, inclusive
Exclusion 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