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Looking for participantsPhase3

A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

Sponsor: Pfizer

NCT ID: NCT06641466

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Rimegepant (drug), Placebo Comparator (drug), Standard of Care (drug), Rimegepant (drug)
How long the study runs
Study runs about 24 months (dates as stated)
About the drug or intervention
Rimegepant — drug: Rimegepant 75 mg ODT for 7 days · Placebo Comparator — drug: Matching placebo oral disintegrating tablets for 7 days · Standard of Care — drug: Standard of care for acute treatment as needed · Rimegepant — drug: Rimegepant 75 mg ODT for acute treatment as needed
Patient visit burden
Not specified by the sponsor

In plain English

This study, run by Pfizer, is testing a medicine called rimegepant in women to see if it can help prevent menstrual migraine when taken from time to time rather than every day. Menstrual migraine is a migraine attack linked to a woman's period.

Who can take part

  • You have regular periods, with cycles between 24 and 34 days.
  • You have had migraine (with or without warning signs called aura) for at least 1 year.
  • You have had menstrual migraine attacks for at least 3 months.
  • You had at least 1 migraine attack around your period in at least 2 of your last 3 periods before joining the study.
  • If you take a daily medicine to prevent migraine, the dose must have been the same for at least 3 months and must not change during the study.

Who may not be able to

  • You have more than 6 migraine days a month outside the time around your period in the past 3 months.
  • You have chronic migraine or more than 14 headache days a month on average in the past 3 months.
  • You have had certain rare migraine types affecting the eye, vision at the back of the head, or causing weakness on one side of the body.
  • You have schizophrenia, bipolar disorder, or borderline personality disorder.
  • You have other long-term pain conditions (such as fibromyalgia), significant nerve or brain conditions other than migraine, or other medical conditions, including hormone or gynaecological problems such as severe period pain.

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years to 45 Years
Who
Female
Number of participants
723
Started
2025-03-11
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for menstrual migraine
  • • Phase3 - 723 participants
  • • The purpose of this study is to evaluate the efficacy and safety of rimegepant when administered during the peri-menstrual period (PMP) for intermittent prevention of migraine in women who experience menstrual migraine attacks

Who can take part?

  • • Ages 18 Years to 45 Years
  • • Diagnosed with menstrual migraine
  • • Female only

Where?

  • • Bristol - West Walk Surgery
  • • Milton Keynes - Bioluminux
  • • Hull - Hull University Teaching Hospitals NHS Trust
  • • London - Re:Cognition Health - London
  • • +4 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The purpose of this study is to evaluate the efficacy and safety of rimegepant when administered during the peri-menstrual period (PMP) for intermittent prevention of migraine in women who experience menstrual migraine attacks.

Menstrual Migraine

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 45 Years
  • Who can join: Female only

What the study is looking for

  • ✓Participant has regular menstrual cycles ≥24 days and ≤34 days
  • ✓A minimum 1-year history of migraine (with or without aura) consistent with a diagnosis according to the...
  • ✓A history of menstrual migraine attacks of at least 3 months
  • ✓Participant reported history of experiencing at least 1 migraine attack during the perimenstrual period in at least...

Who cannot take part

  • ✗Greater than 6 migraine days per month that are outside of the perimenstrual period in the 3 months prior to Screening
  • ✗A diagnosis of chronic migraine or a history of more than 14 headache days per month on average, in the 3 months...
  • ✗History of retinal migraine, basilar migraine or hemiplegic migraine
  • ✗Current diagnosis of schizophrenia, bipolar, or borderline personality disorder
See the full criteria
Inclusion Criteria: 1. Participant has regular menstrual cycles ≥24 days and ≤34 days 2. A minimum 1-year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition 3. A history of menstrual migraine attacks of at least 3 months 4. Participant reported history of experiencing at least 1 migraine attack during the perimenstrual period in at least 2 out of 3 menstrual cycles immediately prior to screening. 5. If the participant is receiving a permitted background continuous prophylactic migraine medication, the medication dose must be stable for at least 3 months prior to the Screening visit and, the dose is not expected to change during the course of the study Exclusion Criteria: 1. Greater than 6 migraine days per month that are outside of the perimenstrual period in the 3 months prior to Screening 2. A diagnosis of chronic migraine or a history of more than 14 headache days per month on average, in the 3 months prior to Screening 3. History of retinal migraine, basilar migraine or hemiplegic migraine 4. Current diagnosis of schizophrenia, bipolar, or borderline personality disorder 5. Other pain syndromes (eg, fibromyalgia, complex regional pain syndrome), or significant neurological disorders (other than migraine), or other medical conditions (including endocrine and gynecological eg, severe dysmenorrhea

Where Is This Study? (8 UK sites)

West Walk Surgery

Bristol BS37 4AX, United Kingdom

Recruiting

Bioluminux

Milton Keynes MK15 0DU, United Kingdom

Recruiting

Hull University Teaching Hospitals NHS Trust

Hull HU3 2JZ, United Kingdom

Recruiting
Hospital R&D contact (matched)

James Illingworth

hyp-tr.development.research@nhs.net01482 461883 or 461903

Re:Cognition Health - London

London W1G 8TA, United Kingdom

Recruiting

The Walton Centre NHS Foundation Trust

Fazakerley L9 7LJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Jonathan McGregor

wcft.rdi@nhs.net0151 556 3748

Panthera Clinic - York

York YO24 4LJ, United Kingdom

Recruiting

Panthera Biopartners - Glasgow

Glasgow G51 4TY, United Kingdom

Recruiting

Panthera Biopartners - Sheffield

Sheffield S2 5FX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alessia Dunn

STH.ResearchAdministration@nhs.net0114 2712550

How to Get in Touch

Pfizer CT.gov Call Center

Sponsor contact

CONTACT

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-07