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

NCT06728345 | Not Yet Recruiting

• 1 other identifier: No.2024-454
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 1.To evaluate the change from baseline in the mean number of migraine days per month during weeks 1-12
2. 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

Conditions

Migraine; Migraine Prophylaxis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Mean change from the baseline in the number of moderate or severe migraine days per month over the entire treatment phase (Weeks 1-12)

  The treatment period is 12 weeks

• Mean change from baseline in the Migraine Disability Assessment (MIDAS)

  Baseline, Week 12

• Mean change from baseline in the migraine disability (HIT-6)

  Baseline , Week 4,8,12

• Mean change from baseline in the Patient Health Questionnaire (PHQ-9)

  Baseline , Week 4,8,12

• Mean change from baseline in the Generalized Anxiety Disorder -7 (GAD-7)

  Baseline , Week 4,8,12

Study Arms (1)

female migraine patients who recevie Rimegepant as prophylactic treatment

Drug: Rimegepant

Interventions

Rimegepant DRUG

Female migraine patients take Rimegepant (75mg QOD) as their regular prophylactic treatment of migraine for 12 weeks

female migraine patients who recevie Rimegepant as prophylactic treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• Subjects who are allergic to rimegepant or any of its excipients.
• Patients with severe liver damage or end-stage renal disease.
• 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.
• Any condition deemed by the investigator that might affect the patient's participation in the study.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

MeSH Terms

Conditions

Migraine Disorders

Interventions

rimegepant sulfate

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

HongRu Zhao, M.D

CONTACT

18051212086; tiantan11@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 11, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share