A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals

Brief summary (registry, in English)

Background and Objectives: Medical professionals frequently work night shifts and rotating schedules. Night shift work, accompanied by sleep deprivation and stress, is a significant trigger for migraine attacks. Traditional preventive migraine medications usually require continuous administration and gradual dose titration, making them unsuitable for short-term, intermittent prevention specifically during night shifts. Rimegepant, a small-molecule CGRP receptor antagonist orally disintegrating tablet, has a rapid onset of action and a relatively short half-life, making it suitable for intermittent administration (i.e., situational prevention) prior to predictable periods of high migraine risk. This study aims to evaluate whether administering Rimegepant 75 mg orally within 2 hours before the start of a night shift and at the end of the night shift can effectively prevent moderate-to-severe migraine during the night shift and the 24-hour post-shift observation window. Study Design: This is a prospective, open-label, randomized, two-cycle crossover clinical study conducted in China. Approximately 260 eligible participants are planned to be enrolled. After a 4-week screening/baseline observation period, participants will be randomized 1:1 to one of two treatment sequences: Sequence A: Rimegepant situational preventive treatment in Treatment Period 1, followed by a 10-day washout period, and standard care in Treatment Period 2. Sequence B: Standard care in Treatment Period 1, followed by a 10-day washout period, and Rimegepant situational preventive treatment in Treatment Period 2. Each treatment period lasts 4 weeks. Subsequently, all participants will enter a 4-week open-label extension period to receive Rimegepant treatment. Target Population: Study Population: Clinicians or nurses aged 18-60 working in Chinese hospitals. Key Inclusion Criteria: Diagnosis of migraine (with or without aura) according to ICHD-3 criteria; at least 1 migraine attack occurring in the night-shift-related observation window per month over the past 3 months; at least 1 moderate-to-severe migraine attack during the 4-week screening period; ability to complete the electronic diary (eDiary). Key Exclusion Criteria: Patients with chronic migraine; history of hepatic or renal impairment; history of hypersensitivity to CGRP receptor antagonists; participation in another clinical study within the past 3 months; pregnant or breastfeeding women, etc. Primary Outcome Measures: Primary Endpoint: The mean number of moderate-to-severe migraine days per evaluable night-shift-related observation window during each 4-week treatment period (assessed via eDiary). Key Secondary Endpoints: Mean headache/migraine days within the night-shift-related observation window; number of moderate-to-severe migraine attacks during the night shift; days of acute migraine medication use; and changes in scale scores including sleep quality (PSQI), quality of life (MSQoL), and headache impact (HIT-6). Significance: The results of this study are expected to provide a feasible, effective, and targeted situational preventive strategy for migraine for medical professionals, a high-risk occupational population, and to provide clinical evidence for migraine management in similar short-term high-risk scenarios.

What you commit to

• Study type: Interventional
• Planned participants: 260
• From Dec 2026 to the primary completion date, Jun 2027
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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