The Real-world Study of Rimegepant Treatment in Female Migraine Patients of China

The Real-world Study of Rimegepant for the Preventive Treatment in Female Migraine Patients

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

Study Overview

• Status: Not yet recruiting
• Conditions: Migraine; Migraine Prophylaxis
• Intervention / Treatment: Drug: Rimegepant

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: HongRu Zhao, M.D; Phone Number: 18051212086; Email: tiantan11@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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

Description

Inclusion Criteria:

1. Female participants aged ≥ 18 years-old
2. Primary diagnosis of migraine according to ICHD-3 3.4 or more migraine days during Observation Period and Screening Visit

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:

1. Patients diagnosed with secondary headaches.
2. Women who are pregnant or breastfeeding.
3. 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.
4. Subjects lacking the equipment to complete questionnaires on a digital platform.
5. Subjects who are allergic to rimegepant or any of its excipients.
6. Patients with severe liver damage or end-stage renal disease.
7. Patients with a medical history indicating the presence of uncontrolled or unstable cardiovascular disease (such as ischemic heart disease, coronary artery spasm, or cerebral ischemia), or those who have had a myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, cardiac surgery, stroke, or transient ischemic attack within 6 months prior to the screening visit.
8. Any condition deemed by the investigator that might affect the patient's participation in the study.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
female migraine patients who recevie Rimegepant as prophylactic treatment	Drug: Rimegepant; Female migraine patients take Rimegepant (75mg QOD) as their regular prophylactic treatment of migraine for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	The treatment period is 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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	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	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	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	Baseline , Week 4,8,12

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Soochow University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 6, 2024
• First Submitted That Met QC Criteria: December 6, 2024
• First Posted (Estimated): December 11, 2024

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: No.2024-454

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes