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NCT Number: NCT06221267

A Registry Study on Rimegepant for the Treatment of Migraine Participants in Guangdong-Hong Kong-Macao Greater Bay Area

This study is a single-arm, prospective, multicenter, observational registry study. It plans to enroll 120 migraine patients who meet the inclusion criteria and are treated with rimegepant in selected hospital outpatient clinics in the Greater Bay Area. The main purpose of this study is to observe the effectiveness of rimegepant in treating migraines in a real-world clinical setting, including the impact of rimegepant on the quality of life, functioning, productivity status of migraine patients, and patients' satisfaction with the use of rimegepant in treating migraines.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510120, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants with headaches that meet the diagnostic criteria for migraines according to the International Classification of Headache Disorders, 3rd edition (ICHD-3), with or without aura.
  • Patients prescribed rimegepant by the attending physician for the treatment of migraines.
  • Signed informed consent form.
  • Age greater than 18 years.
  • Not concurrently participating in other interventional clinical studies.

Exclusion criteria

  • Patients diagnosed with secondary headaches.
  • Patients with severe visual, auditory, language, intellectual, memory, consciousness impairments or other conditions that prevent them from completing the questionnaire and follow-up.
  • Pregnant or lactating female patients.
  • Patients deemed by the investigator as unsuitable for participation in the study or unable to complete the 4-week follow-up.
  • Patients with a known history of hypersensitivity reactions to rimegepant or its components.
  • Evidence in the medical history suggesting the presence of uncontrolled or unstable cardiovascular diseases (such as ischemic heart disease, coronary artery vasospasm, or cerebrovascular ischemia), or a history of myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, cardiac surgery, stroke, or transient ischemic attack within the past 6 months before the screening visit.

Treatment and study plan

Rimegepant

Drug

No intervention. The study will record the usage, timing, frequency, and dosage of rimegepant in a real-world clinical setting.

Primary outcomes

  1. Treatment Satisfaction Questionnaire for Medication (TSQM)

    Time frame: 4 weeks

    Treatment Satisfaction Questionnaire for Medication (TSQM) score for migraine patients' satisfaction with treatment of rimegepant

  2. European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L)

    Time frame: 4 weeks

    European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) score for the impact of rimegepant on the quality of life of migraine patients

  3. Headache Impact Test-6 (HIT-6)

    Time frame: 4 weeks

    Headache Impact Test-6 (HIT-6) score for the impact of rimegepant on the functioning of migraine patients

  4. Work Productivity and Activity Impairment-General Health (WPAI-GH)

    Time frame: 4 weeks

    Work Productivity and Activity Impairment-General Health (WPAI-GH) score for the impact of rimegepant on the productivity and work efficiency of migraine patients

Sponsors and collaborators

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 24, 2024
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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