A Study to Find Out if the Medicine Called Rimegepant is Safe for Adults in India

NCT07685769 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: C4951088
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multicenter, single-arm, open-label Phase 4 study evaluating the safety and tolerability of rimegepant 75 mg orally disintegrating tablet (ODT) for the acute treatment of migraine (with or without aura) in adult patients in India who have had an insufficient response, intolerance, or contraindication to triptans. It will enroll approximately 60 participants.

Conditions

Acute Treatment of Migraine

Keywords

migraine; Rimegepant

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-emergent adverse events (TEAEs)

  Up to 28 days

• Incidence of Serious adverse events (SAEs)

  up to 28 days

Secondary Outcomes (2)

• Incidence of clinically significant vital signs abnormalities

  up to 28 days

• Absolute score on treatment satisfaction questionnaire for medication (TSQM-9) subscales

  2-7 days after taking study drug

Study Arms (1)

Rimegepant 75 mg ODT

OTHER

Rimegepant 75 mg ODT (1 tablet) PRN at the time of migraine attack

Drug: Rimegepant 75 mg ODT

Interventions

Rimegepant 75 mg ODT DRUG

Rimegepant 75 mg ODT (1 tablet) PRN at the time of migraine attack

Rimegepant 75 mg ODT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are eligible to be included in this study only if all of the following criteria apply:
• Age and Reproductive Status:
• years of age or older who meet the reproductive criteria.
• Disease Characteristics:
• Participant has at least a 1-year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:
• At least 5 attacks fulfilling criteria 1-3:
• Headache attacks lasting 4-72 hours (when untreated or unsuccessfully treated).
• Headache has at least 2 of the following 4 characteristics:
• Unilateral location
• Pulsating quality
• Moderate or severe pain intensity
• Aggravation by or causing avoidance of routine physical activity (eg, walking or climbing stairs)
• During headache, at least 1 of the following:
• Nausea and/or vomiting
• Photophobia and phonophobia

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Medical Conditions:
• Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
• PHQ-8 total score ≥15
• a positive response to item 1 or 2 of the C-SSRS within 30 days prior to Screening;
• suicidal ideation associated with actual intent and/or a method or plan at any time in their lifetime: any positive response on items 3, 4 or 5 of the C-SSRS;
• any previous lifetime history of suicidal behavior: "Yes" to answer to any of the suicidal behavior items of the C-SSRS.
• Current diagnosis of schizophrenia, bipolar, or borderline personality disorder.
• History of severe drug allergy, including anaphylaxis or known hypersensitivity or intolerance to rimegepant or any of its excipients.
• Any of the following:
• History of any trigeminal autonomic cephalalgia (eg. cluster headache, Short-lasting, Unilateral, Neuralgiform headache attacks with Conjunctival injection and Tearing \[SUNCT\], Short-lasting unilateral neuralgiform headache attacks with cranial autonomic symptoms \[SUNA\], hemicrania continua, paroxysmal hemicrania).
• 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.
• Prior/Concomitant Therapy:
• Current use of any prohibited concomitant medication(s).
• History of use of ergotamine medications or triptans for greater than/equal to 10 days per month on a regular basis for greater than/equal to 3 months, or history of non-narcotic analgesic intake for greater than/equal to 15 days per month for greater than/equal to 3 months (eg, acetaminophen, non-steroidal anti-inflammatory drugs \[NSAIDs\], gabapentin) for other pain indications.

Sponsors & Collaborators

• Pfizer: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Migraine Disorders

Interventions

rimegepant sulfate

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: July 17, 2026
• Primary Completion (Estimated): January 11, 2028
• Study Completion (Estimated): January 11, 2028
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share