The Real-world Study of Rimegepant Treatment in Female Migraine Patients of China
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-65
SponsorThe First Affiliated Hospital of Soochow University
About this trial
The goal of this observational study is to learn about the effects and safety of Rimegepant in women, especially young and middle-aged women, who take Rimegepant to treat their migraine in the real world. Participants already taking Rimegepant (75mg QOD) as their regular preventive treatment of migraine for 12 weeks will be evaluated as the followings :
1. To evaluate the change from baseline in the mean number of migraine days per month during weeks 1-12 2. To evaluate the number of participants that have least a 50% reduction from baseline in the mean number of migraine days per month during weeks 1-12
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female participants aged ≥ 18 years-old
Primary diagnosis of migraine according to ICHD-3 3.4 or more migraine days during Observation Period and Screening Visit
Disqualifiers
Patients diagnosed with secondary headaches.
Women who are pregnant or breastfeeding.
Subjects with severe impairments in language, vision, memory, or cognitive function that affect communication and understanding, or those who are unable to complete questionnaires or follow-ups.
Subjects lacking the equipment to complete questionnaires on a digital platform.
Trial population
Female patients diagnosed with migraine (with or without aura) who take rimegepant rimegepant 75 mg orally disintegrating tablet every other day for 12 weeks
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Rimegepant
DrugFemale migraine patients take Rimegepant (75mg QOD) as their regular prophylactic treatment of migraine for 12 weeks
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: female migraine patients who recevie Rimegepant as prophylactic treatment1 intervention
Trial outcomes
Primary outcomes
1
Mean change from the baseline in the number of migraine days per month over the entire treatment phase (Weeks 1-12)
Change from baseline in mean number of migraine days per month
Time frame
The treatment period is 12 weeks2
Proportion of subjects with > 50% reduction from the baseline (Weeks 1 to 12)
Number of migraine days per month over the entire treatment phase
Time frame
The treatment period is 12 weeksSecondary outcomes
1
Mean change from the baseline in the number of moderate or severe migraine days per month over the entire treatment phase (Weeks 1-12)
Change from baseline in mean number of moderate or severe migraine days per month
Time frame
The treatment period is 12 weeks2
Mean change from baseline in the Migraine Disability Assessment (MIDAS)
Changes in MIDAS score across rimegepant treatment. Participants provide the number of missed work or school days; missed household chores days; missed social or leisure activity days; and days at work or school, and separately at home, where productivity was reduced by half or more in the last 3 months (scale: 0 - 90 for each of 5 subscales). The 5 subscale scores are summed to compute the MIDAS total score (scale: 0 - 450). Lower scores indicate less headache-related disability.
Time frame
Baseline, Week 123
Mean change from baseline in the migraine disability (HIT-6)
Changes in Headache Impact Test-6 questionnaire across rimegepant treatment. Headache Impact Test (HIT-6) is a measure of headache severity and provides information regarding the effect of headache on other domains related to functional participation. The HIT-6 has six questions and the range goes from 36 (best outcome) to a maximum score of 78 (worst outcome). Higher HIT-6 scores indicate increased headache severity and greater functional limitations
Time frame
Baseline , Week 4,8,124
Mean change from baseline in the Patient Health Questionnaire (PHQ-9)
Changes in PHQ-9 questionnaire across rimegepant treatment. PHQ-9 scoring uses a 4-point Likert scale: 0 = "Not at all," 1 = "Some days," 2 = "More than half the days," and 3 = "Almost every day." With a total score ranging from 0 to 27
Time frame
Baseline , Week 4,8,12Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: