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

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.