An interventional study of Rimegepant 75 mg ODT and Standard Care in Migraine Disorders, sponsored by Chinese PLA General Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Chinese PLA General Hospital · Not applicable, Interventional, and Prevention
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.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's planned enrollment of 260 is above the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Chinese PLA General Hospital is the lead sponsor of 570 studies on the registry; 207 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 .
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:
History of 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 (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 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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
"Treatment Period 1: Rimegepant 75 mg ODT situational prevention. Treatment Period 2: Standard care."
Drug: Rimegepant 75 mg ODT · Other: Standard Care
Treatment Period 1: Standard care. Treatment Period 2: Rimegepant 75 mg ODT situational prevention.
Drug: Rimegepant 75 mg ODT · Other: Standard Care
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.
Standard Care
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.
Time frame: Up to 8 weeks (Treatment Period 1 and Treatment Period 2)
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
Time frame: 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.
Time frame: 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.
Time frame: 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 .
Time frame: Baseline, Week 4, Week 8, and Week 14
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Rimegepant
Chinese PLA General Hospital →