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NCT Number: NCT06641466

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

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.

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Key information

Conditions

Menstrual Migraine

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Fundación para la lucha contra las enfermedades neurológicas de la infancia, CABA, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 International Classification of Headache Disorders, 3rd Edition
  • 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 2 out of 3 menstrual cycles immediately prior to screening.
  • 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

  • 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 prior to Screening
  • History of retinal migraine, basilar migraine or hemiplegic migraine
  • Current diagnosis of schizophrenia, bipolar, or borderline personality disorder
  • 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

Treatment and study plan

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

Primary outcomes

  1. Mean change from the Observation Period in number of migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase

    Time frame: 5 months (5 menstrual cycles)

    Change from Observation Period in the number of migraine days per the 5-day perimenstrual period

Secondary outcomes

  1. Mean change from the Observation Period in number of headache days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase

    Time frame: 5 months (5 menstrual cycles)

    Change from the Observation Period in number of headache days per 5-day perimenstrual period

  2. Percentage of participants with ≥50% reduction from the Observation Period in number of migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase (50% responder)

    Time frame: 5 months (5 menstrual cycles)

    Patients with ≥50% reduction from the Observation Period in number of migraine days per 5-day perimenstrual period

  3. Mean change from the Observation Period in number of acute migraine medication days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase

    Time frame: 5 months (5 menstrual cycles)

    Change from the Observation Period in number of acute migraine medication days per 5-day perimenstrual period

  4. Mean change from the Observation Period in number of acute migraine-specific medication days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase

    Time frame: 5 months (5 menstrual cycles)

    Change from the Observation Period in number of acute migraine specific medication days per 5-day perimenstrual period

  5. Mean change from the Observation Period in number of migraine days with moderate-severe functional disability per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase

    Time frame: 5 months (5 menstrual cycles)

    Change from the Observation Period in number of migraine days with moderate-severe functional disability per 5-day perimenstrual period

  6. Mean change from the Observation Period in number of moderate-severe headache days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase

    Time frame: 5 months (5 menstrual cycles)

    Change from the Observation Period in number of moderate-severe headache days per 5-day perimenstrual period

  7. Mean change from the Observation Period in number of moderate-severe migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase

    Time frame: 5 months (5 menstrual cycles)

    Change from the Observation Phase in number of moderate-severe migraine days per 5-day perimenstrual period

  8. Mean change from baseline in the MiCOAS Cognition score at postdosing (ie, 1 day after the 7-day dosing period) across each cycle of the Double-Blind Treatment Phase

    Time frame: 5 months (5 menstrual cycles)

    Change from baseline in the MiCOAS Cognition score at post-dosing across each cycle

  9. Mean change from the Observation Period in monthly migraine days (per cycle, normalized to 28-days) across each cycle of the Double-Blind Treatment Phase

    Time frame: 5 months (5 menstrual cycles)

    Change from the Observation Phase in monthly migraine days

  10. Mean change from the Observation Period in monthly headache days (per cycle, normalized to 28-days) across each cycle of the Double-Blind Treatment Phase

    Time frame: 5 months (5 menstrual cycles)

    Change from the Observation Phase in monthly headache days

  11. Mean change from the Observation Phase in monthly acute migraine-specific medication days (per cycle, normalized to 28-days) across each cycle of the Double-Blind Treatment Phase

    Time frame: 5 months (5 menstrual cycles)

    Change from the Observation Phase in monthly acute migraine-specific medication days

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, PARALLEL GROUP STUDY TO INVESTIGATE INTERMITTENT PREVENTION OF MENSTRUAL MIGRAINE WITH RIMEGEPANT COMPARED WITH PLACEBO IN WOMEN PARTICIPANTS 18 TO 45 YEARS OF AGE

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Oct 15, 2024
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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