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Efficacy and Tolerability of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use

PHASE4RECRUITING

This study is being conducted to evaluate the efficacy and tolerability of rimegepant in a population of adults that are unsuitable for triptan medications due to a previous intolerance, lack of efficacy, or contraindication (including a history of clinically-relevant cardiovascular disease).

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Study details:

This study is being conducted to evaluate the efficacy and tolerability of rimegepant in a population of adults that are unsuitable for triptan medications due to a previous intolerance, lack of efficacy, or contraindication (including a history of clinically-relevant cardiovascular disease). Rimegepant will be further evaluated in this population with as needed use in a 12-week, open-label extension study.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age.
  • Migraine attacks, on average, lasting about 4 - 72 hours if untreated.
  • 4 to 14 migraine days per month on average across the 3 months prior to the Screening Visit (month is defined as 28 days for the purpose of this protocol).
  • Less than 15 headache days (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and throughout the Screening Phase.
  • Subjects must be able to distinguish migraine attacks from tension/cluster headaches.
  • Subjects on prophylactic migraine medication (excluding CGRP antagonists) are permitted to remain on therapy if they have been on a stable dose for at least 3 months (12 weeks) prior to the Screening Visit, and if the dose is not expected to change during the course of the study.
  • Triptan unsuitable

    • Exclusion criteria

  • History of cluster headache, basilar migraine, or hemiplegic migraine
  • Current medication overuse headaches
  • Headaches occurring 15 or more days per month (migraine or non-migraine) in any of the 3 months prior to the Screening Visit
  • Active chronic pain syndrome (such as fibromyalgia, chronic pelvic pain, complex regional pain syndrome [CRPS])
  • Other pain syndromes (including trigeminal neuralgia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, interfere with study assessments of safety or efficacy
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2022-10-18

    Primary completion: 2025-05-19

    Study completion finish: 2025-08-25

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE4

    trial

    Trial ID

    NCT05509400

    Intervention or treatment

    DRUG: Rimegepant

    DRUG: Placebo

    DRUG: Rimegepant

    Conditions

    • • Migraine
    Image related to Migraine

    • Condition: Migraine

    • DRUG: Rimegepant and other drugs

    • Melbourne, Victoria, Australia and more

    • Sponsor: Pfizer

    You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

    Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

    Find a site

    Closest Location:

    Alfred Hospital

    Research sites nearby

    Select from list below to view details:

    • Alfred Hospital

      Melbourne, Victoria, Australia

    • USC Clinical Trials Centre

      Sippy Downs, Queensland, Australia

    • PainMedSA & CerCare Pty Ltd

      Wayville, South Australia, Australia

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    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?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: Rimegepant
    • Rimegepant - Double-blind (DB) Phase: One dose of rimegepant 75 mg Oral Disintegrating Tablet (ODT)
    • Rimegepant/Rimegepant - Open-label Extension (OLE) Phase: participants receive one dose rimegepant 75 mg ODT as needed for a qualifying acute migraine. A qualifying migraine is an attack of moderate or severe headache pain intensity. Migraine headache pain intensity will be measured on a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe)
    DRUG: Rimegepant
    • DB Phase: Rimegepant 75 mg Orally Disintegrating Tablet (ODT)
    PLACEBO_COMPARATOR: Placebo
    • Placebo - Double-blind (DB) Phase: One dose of matching placebo
    • Placebo/Rimegepant - Open-label Extension (OLE) Phase: participants receive one dose rimegepant 75 mg ODT for a qualifying migraine
    DRUG: Placebo
    • DB Phase: matching placebo

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Compare the efficacy of rimegepant with placebo in the acute treatment of migraine, as measured by migraine headache pain relief at 2-hours post-dose during the Double-Blind Treatment (DBT) Phase.Migraine headache pain relief will be assessed using the percentage of subjects with a headache pain intensity of none or mild. Migraine headache pain intensity will be measured on a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe).2 hours post-dose

    Secondary outcome

    Frequently Asked Questions

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    You may be eligible to participate in this trial based on your search.Apply for study
    Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

    References

    Clinical Trials Gov: Efficacy and Tolerability of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use

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