An observational study in Migraine and Migraine Prophylaxis, sponsored by The First Affiliated Hospital of Soochow University. Not yet recruiting. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-12-11.
Sponsored by The First Affiliated Hospital of Soochow University · Observational
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 :
This single arm, prospective, multi-center, observational registry study aim to evaluate effectiveness of rimegepant as preventive migraine treatment in the real-world setting.
About 300 adult migraine participants will be enrolled continuously at 6 sites with a headache clinic or headache center in China. Subjects who meet the inclusion criteria will be enrolled and will participate in the study. Baseline data including demographic information, socio-economic information, physical examination, medical history, migraine history and past use of headache medications will be collected at the baseline visit. The treatment period will last for 12 weeks during which patients will take rimegepant 75 mg orally disintegrating tablet every other day. The efficacy of rimegepant measured by the reduction in the number of migraine days per month. Subjects will be asked to keep a headache diary to collect monthly headache and migraine days, migraine severity, associated symptoms and drug consumption. Data will be collected at baseline and every month. At study visits, participants will complete the Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder -7 (GAD-7), Headache Impact Test-6 (HIT-6), Pittsburgh Sleep Quality Index (PSQI) at weeks 4, 8 and 12; and participants will complete the Migraine Disability Assessment (MIDAS) at weeks 12.
1,558 studies on the registry are indexed under Migraine Disorders; 301 are open to participants now.
This study's planned enrollment of 300 is above the median of 130 across 306 observational studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →The First Affiliated Hospital of Soochow University is the lead sponsor of 258 studies on the registry; 149 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Female patients diagnosed with migraine (with or without aura) who take rimegepant rimegepant 75 mg orally disintegrating tablet every other day for 12 weeks
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
4.Migraine attacks present for more than 1 year 5.Rimegepant is prescribed for the preventive treatment of migraine by physician 6.Written informed consent must be obtained before participant is enrolled 7.Not concurrently participating in other interventional clinical studies.
Exclusion Criteria:
Drug: Rimegepant
Female migraine patients take Rimegepant (75mg QOD) as their regular prophylactic treatment of migraine for 12 weeks
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 weeks
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 weeks
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 weeks
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 12
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 4,8,12
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 4,8,12
Mean change from baseline in the Generalized Anxiety Disorder -7 (GAD-7)
Anxiety level is measured with Generalized Anxiety Disorder 7-item (GAD-7) which is a tool based on seven items which are scored from zero to three. The whole scale score can range from 0 to 21 and cut-off scores for mild, moderate and severe anxiety symptoms are 5, 10 and 15 respectively
Time frame: Baseline , Week 4,8,12
Mean change from baseline in the Pittsburgh Sleep Quality Index (PSQI)
Changes in PSQI questionnaire across rimegepant treatment. PSQI is a self-rated questionnaire for sleep quality. It includes 18 items across 7 components; C1: Sleep quality, C2: Sleep latency, C3: Sleep duration, C4: Sleep efficiency, C5: Sleep
Time frame: Baseline , Week 4,8,12
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of Soochow University →