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

A Prospective, Open-label, Randomized, Two-period Crossover Study of Rimegepant for Intermittent / Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Migraine Disorders
• Intervention / Treatment: Drug: Rimegepant 75 mg ODT; Other: Standard Care

• Study Type: Interventional
• Enrollment (Estimated): 260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhao Dong; Phone Number: (+86) 010-55499218; Email: dong_zhaozhao@126.com
• Study Contact Backup: Name: Ye Ran; Phone Number: (+86) 010-55499319; Email: ranyenk@126.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Chinese People's Liberation Army General Hospital, First Medical Center
      • Contact: Zhao Dong; Phone Number: (+86) 010-55499218; Email: dong_zhaozhao@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female, aged 18 to 60 years.

Diagnosis of migraine (with or without aura) according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria.

Employed as a clinical doctor or nurse; self-reported at least 1 migraine attack occurring in the night-shift-related observation window per month over the past 3 months; and anticipated no substantial change in the night shift rotation cycle before study completion.

At least one moderate-to-severe migraine attack occurring in the night-shift-related observation window during the 4-week screening period.

Able to understand and comply with electronic diary entries, complete related scales, and provide written informed consent.

The start times of two consecutive eligible night shifts must be separated by at least 4 calendar days (inclusive of the 4th day).

Participants may continue medications with potential migraine-preventive effects, regardless of symptoms, provided the dose has been stable for at least 3 months (12 weeks) prior to the screening period and is not expected to change. (Excludes CGRP monoclonal antibodies or receptor antagonists).

Exclusion Criteria:

• Patient-reported 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.

Chronic migraine.

Uncontrolled, unstable, or newly diagnosed cardiovascular disease (e.g., ischemic heart disease, coronary vasospasm, or cerebral ischemia); or participants who have had a myocardial infarction, acute coronary syndrome (ACS), percutaneous coronary intervention (PCI), cardiac surgery, stroke, or transient ischemic attack (TIA) within 6 months prior to the screening period.

Current or past diagnosis of schizophrenia, bipolar disorder, borderline personality disorder, or severe mood disorders including depression and anxiety.

Concomitant use of other small-molecule CGRP receptor antagonists for acute treatment, or use of strong CYP3A4 inhibitors or strong/moderate CYP3A4 inducers, which may significantly affect rimegepant exposure.

Current use of any CGRP-targeted preventive treatment, including monoclonal antibodies against CGRP or its receptor, and small-molecule CGRP receptor antagonists.

Use of rimegepant outside the designated rimegepant treatment periods as situational preventive treatment, or as acute

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence A: Rimegepant Situational Prevention then Standard Care; "Treatment Period 1: Rimegepant 75 mg ODT situational prevention. Treatment Period 2: Standard care."	Drug: Rimegepant 75 mg ODT; Administered orally as a 75 mg ODT within 2 hours before the start of the night shift and at the end of the night shift.; Other: Standard Care; Standard Care
Active Comparator: Sequence B: Standard Care then Rimegepant Situational Prevention; Treatment Period 1: Standard care. Treatment Period 2: Rimegepant 75 mg ODT situational prevention.	Drug: Rimegepant 75 mg ODT; Administered orally as a 75 mg ODT within 2 hours before the start of the night shift and at the end of the night shift.; Other: Standard Care; Standard Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean number of moderate-to-severe migraine days per evaluable night-shift-related observation window	The mean number of moderate-to-severe migraine days per evaluable night-shift-related observation window during each 4-week treatment period, calculated as the total number of moderate-to-severe migraine days across all evaluable windows divided by the total number of evaluable windows. A moderate-to-severe migraine day is defined as a migraine day with a peak VAS pain score ≥ 4.	Up to 8 weeks (Treatment Period 1 and Treatment Period 2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean number of headache days per evaluable night-shift-related observation window	The mean number of headache days per evaluable night-shift-related observation window during each 4-week treatment period	Up to 8 weeks (Treatment Period 1 and Treatment Period 2)
Number of moderate-to-severe migraine attacks during night shifts	The number of moderate-to-severe migraine attacks occurring during the night shift in each 4-week treatment period.	Up to 8 weeks (Treatment Period 1 and Treatment Period 2)
Mean number of acute migraine medication use days	The mean number of acute migraine medication use days per evaluable night-shift-related observation window during each 4-week treatment period.	Up to 8 weeks (Treatment Period 1 and Treatment Period 2)
Change from baseline in Migraine-Specific Quality of Life Questionnaire (MSQoL v2.1) scores	Change from baseline in Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQoL v2.1) scores. The MSQoL v2.1 is a 14-item questionnaire. The minimum and maximum values for the total score range from 0 to 100, where higher scores indicate a better quality of life .	Baseline, Week 4, Week 8, and Week 14

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: October 30, 2026
• First Submitted That Met QC Criteria: November 4, 2026
• First Posted (Actual): November 5, 2026

Study Record Updates

• Last Update Posted (Actual): November 5, 2026
• Last Update Submitted That Met QC Criteria: November 4, 2026
• Last Verified: October 1, 2026

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; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care; rimegepant sulfate
• Other Study ID Numbers: S2026-851-01

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