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
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.
∙ 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)
• AND
⁃ Pure Menstrual migraine with aura, either/or
⁃ Menstrually-related migraine with aura, either/or
⁃ Pure Menstrual migraine without aura, either/or
⁃ Menstrually-related migraine without aura
• 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 demonstrated compliance with the electronic headache diary during the 28-day baseline period by entry of headache data on a minimum of 21 days cumulative during the 28-day baseline period (\
∙ diary compliance)
⁃ Three months of regular menstrual cycle prior to baseline period and 1 regular cycle (within 21-28 days) of previous cycle during the baseline run-in period
⁃ Patients not using birth control must have a negative urine beta-human chorionic gonadotrophin(β-HCG) test at the Screening Visit (V1), and must not be in a sexual relationship with a person who produces sperm or must be medically confirmed as sterile. These conditions must be met from the baseline period through the entire duration of study and 5.5 months after the last dose of fremanezumab.
⁃ Patients using birth control must have a negative β-HCG test result and practice a highly effective method of birth control prior to treatment administration and 5.5 months following the last dose of IMP. Birth control permitted should allow estrogen drop and maintenance of monthly cycle: estrogen/progesterone pills; etonogestrel/ethinylestradiol ring; copper intrauterine device (IUD) and progesterone-containing IUD and have been on their current birth control for ≥30 days.
⁃ The patient must be willing and able to comply with study restrictions and attend the clinic for all study visits required for the duration of the study and to attend follow up evaluations, as specified in the protocol