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 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
72
The intervention will be active medication.
The intervention will be placebo injection.
Brigham and Women's Health Care Center
Chestnut Hill, Massachusetts, United States
RECRUITINGMigraine Days
The number of active migraine days during the 24-week treatment period after the 1st dose of study drug.
Time frame: 6 months
Migraine Duration
The number of migraine hours of any severity experienced in the 24-week treatment period.
Time frame: 6 months
Migraine Severity
Headache severity will be subjectively rated by the patient as follows: mild headache, moderate headache, and severe headache.
Time frame: 6 months
Migraine Specific Quality of Life Measure
The Migraine Specific Quality of Life (MSQoL) scale is a 14 item questionnaire that assesses the impact of migraine and migraine treatment on a patient's quality of life during the previous 4 weeks. The MSQoL measures the degree to which performance of normal activities is limited by migraine, the degree to which performance of normal activities is prevented by migraine and the emotional effects of migraine. Scores range from 0 to 100, with higher scores indicating better health-related quality of life.
Time frame: 6 months
Responder Status
Responder status is defined as 50% or more reduction from the 28 day baseline period in the monthly average number of migraine days during the 24 week treatment period.
Time frame: 6 months
Disability (MIDAS)
Mean change from randomization at the end of 24-week treatment period in disability score for overall impact as measured by the Migraine Disability Assessment Test (MIDAS) questionnaire at the following time points: • Weeks 12 and 24 This questionnaire measures the impact of the patient's headaches on their life during the previous 3 months. A higher score on the MIDAS indicates a higher grade of disability. The grade is determined as follows: Grade 1 (scores ranging from 0 to 5): little or no disability; Grade 2 (scores ranging from 6 to 10): mild disability; Grade 3 (scores ranging from 11 to 20): moderate disability; Grade 4 (21 or greater): severe disability.
Time frame: 6 months
Disability (HIT-6)
Mean change from randomization at end of 24-week treatment period in disability score for overall impact as measured by the Headache Impact Test (HIT-6) questionnaire at the following time points: • Weeks 4, 8, 12, 16, 20 and 24 The questionnaire measures the adverse impact of headache on social functioning, role functioning, vitality, cognitive functioning, and psychological distress. It also assesses headache severity. It is scored by a simple summation of the six items and ranges between 36 and 78, with larger scores reflecting greater impact.
Time frame: 6 months
Rescue Medication Use
Decrease from baseline at end of 24-week treatment period in the average use of acute rescue medications per migraine attack.
Time frame: 6 months
Depression (PHQ-9)
The Patient Health Questionnaire (PHQ-9) is a 9-item questionnaire with each item corresponding to 1 criterion of the Diagnostic and Statistical Manual for Mental Disorders 4th edition diagnostic criteria for Major depressive disorder. Each of the items is scored on a scale of 0 ("not at all"), 1 ("several days"), 2 ("more than half the days"), and 3 ("nearly every day") based on the frequency of symptoms during the past 2 weeks. The PHQ-9 is a validated measure for detecting and monitoring depression, anxiety, and somatization. Higher scores indicate higher severity of depressive symptoms.
Time frame: 6 months
Anxiety (GAD-7)
The Generalized Anxiety Disorder Assessment-7 (GAD-7) is a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3 to the response categories of "not at all," "several days," "more than half the days," and "nearly every day" respectively, and adding together the scores for the seven questions. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate, and severe anxiety, respectively.
Time frame: 6 months
Sleep Quality (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. The trend in changes of sleep quality from baseline will be assessed. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Time frame: 6 months
Hormone Levels
Kits will be provided by myLAB Box™ for patients to provide saliva samples for the measurement of estradiol, testosterone, progesterone, DHEA, and cortisol. Measurement of these markers will be taken monthly and the trend in change from baseline will be assessed.
Time frame: 6 months
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