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Efficacy and Safety Study of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens

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ClinicalTrials.gov Identifier: NCT05217927
Recruitment Status : Recruiting
First Posted : February 1, 2022
Last Update Posted : February 20, 2024
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The purpose of this study is to compare the efficacy and safety of daily and every other day dosing of rimegepant to placebo as a preventive treatment for episodic migraine.

Condition or disease Intervention/treatment Phase
Migraine Drug: Rimegepant 75mg daily dosing Drug: Rimegepant 75mg every other day dosing Drug: Placebo comparator dosing Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 660 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 4 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens
Actual Study Start Date : March 4, 2022
Estimated Primary Completion Date : October 9, 2024
Estimated Study Completion Date : February 25, 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: Rimegepant 75mg Orally Disitegrating Tablet (ODT)daily dosing

Double-blind Treatment Phase: Rimegepant 75 mg ODT dosed daily

Open-Label Extension Phase:

Rimegepant 75 mg ODT dosed daily

Drug: Rimegepant 75mg daily dosing
Daily

Experimental: Rimegepant 75mg Orally Disintegrating Tablet (ODT)every other day dosing
Double-blind Treatment Phase: Rimegepant 75 mg ODT every other day dosing alternating with matching placebo
Drug: Rimegepant 75mg every other day dosing
Every other day

Placebo Comparator: Placebo comparator dosing
Double-blind Treatment Phase: matching placebo dosed daily
Drug: Placebo comparator dosing
Placebo comparator




Primary Outcome Measures :
  1. Mean change from the Observation Phase in the number of migraine days per month over the entire Double-blind Treatment Phase (Weeks 1-12) [ Time Frame: 3 months (12 weeks) ]
    Change from baseline in mean number of migraine days per month


Secondary Outcome Measures :
  1. Proportion of subjects with > 50% reduction from the Observation Phase (Weeks 1 to 12). [ Time Frame: 3 months (12 weeks) ]
    Number of moderate to severe migraine days per month over the entire Double-blind Treatment Phase

  2. Mean change from the Observation Phase. [ Time Frame: Weeks 9 to 12 ]
    Number of migraine days per month in the last 4 weeks of the Double-blind Treatment Phase.

  3. Mean change from the Observation Phase [ Time Frame: Weeks 1 to 4 ]
    number of migraine days per month in the first 4 weeks of the Double-blind Treatment Phase.

  4. Mean number of acute migraine-specific medication days per month. [ Time Frame: Weeks 1 to 12 ]
    Over the entire Double-blind Treatment Phase. Acute migraine-specific medications are triptans and ergotamine.

  5. Mean change from baseline in the Migraine-Specific Quality-of-Life Questionnaire (MSQ) restrictive role function. [ Time Frame: At Week 12 ]
    Domain score of the Double-blind Treatment Phase.

  6. Number and percentage of subjects with AEs by intensity. [ Time Frame: 24 Weeks ]
    Serious adverse events (SAEs), AEs leading to study drug discontinuation, and grade 3 to 4 laboratory test abnormalities during the Double-blind Treatment and Open-label Extension Phases.

  7. Number and percentage of subjects treated with rimegepant with AST or ALT elevations. [ Time Frame: 24 Weeks ]
    >3x ULN concurrent (i.e., on the same laboratory collection date) with total bilirubin > 2x ULN during the Double-blind Treatment and Open-label Extension Phases.

  8. Number and percentage of subjects treated with rimegepant with hepatic-related AEs [ Time Frame: 24 Weeks ]
    By intensity and hepatic-related AEs leading to study drug discontinuation during the Double-blind Treatment and Open-label Extension Phases.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1) Target Population: Subject has at least 1 year history of episodic migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:

  1. Age of onset of migraines prior to 50 years of age
  2. Migraine attacks, on average, lasting 4-72 hours if untreated
  3. Per subject report, 4-14 migraine attacks per month within the last 3 months prior to the Screening Visit (month is defined as 4 weeks for the purpose of this protocol

Exclusion Criteria:

  1. Sex and Reproductive Status:

    1. WOCBP who are unwilling or unable to use an acceptable contraceptive method or abstinence to avoid pregnancy for the entire study and for 60 days after the last dose of study drug
    2. Women who are pregnant or breastfeeding
    3. Women with a positive pregnancy test at screening or prior to study drug administration
  2. Prohibited Medications:

    1. Use of prophylactic migraine medication within 30 days prior to the Screening Visit.
    2. History of use of analgesics (e.g., non-steroidal anti-inflammatory drugs [NSAIDs] or acetaminophen) on ≥ 15 days per month during the 3 months (12 weeks) prior to the Screening Visit.
    3. Use of medication accepted for treatment of acute migraine for a nonmigraine indication on ≥ 15 days per month during the 3 months (12 weeks) prior to the Screening Visit.
    4. Subjects who previously discontinued biologic migraine medication must have done so at least 6 months (24 weeks) prior to the Screening Visit.
    5. Subjects taking a prohibited medication as defined per protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05217927


Contacts
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Contact: Pfizer Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05217927    
Other Study ID Numbers: BHV3000-404
C4951010 ( Other Identifier: Alias Study Number )
2021-005239-22 ( EudraCT Number: CTIS (EU) )
2021-005239-22 ( Registry Identifier: CTIS (EU) )
First Posted: February 1, 2022    Key Record Dates
Last Update Posted: February 20, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Migraine
Episodic Migraine
Adult Migraine
Calcitonin Gene-related Peptide
Migraine Prevention
Migraine Prophylaxis
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases