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

November 4, 2026 updated by: Zhao Dong, MD, Chinese PLA General Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
260

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Chinese People's Liberation Army General Hospital, First Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean number of moderate-to-severe migraine days per evaluable night-shift-related observation window
Time Frame: Up to 8 weeks (Treatment Period 1 and Treatment Period 2)

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean number of headache days per evaluable night-shift-related observation window
Time Frame: Up to 8 weeks (Treatment Period 1 and Treatment Period 2)

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
Time Frame: Up to 8 weeks (Treatment Period 1 and Treatment Period 2)

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
Time Frame: Up to 8 weeks (Treatment Period 1 and Treatment Period 2)

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
Time Frame: Baseline, Week 4, Week 8, and Week 14

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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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