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 range18 Years – 45 Years
SexFEMALE
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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
✓. 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
✕. 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