Acute Treatment of MigrainePhase 4NCT07685769
A Study to Find Out if the Medicine Called Rimegepant is Safe for Adults in India
A Phase 4 study testing Rimegepant 75 mg ODT in people with Acute Treatment of Migraine, run by Pfizer at 7 sites in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Treatment of Migraine
- What is being tested?
- Rimegepant 75 mg ODT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesIndia
- Study dates
- 24 Jul 2026to 4 Jan 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants are eligible to be included in this study only if all of the following criteria apply:
- Age and Reproductive Status:
- 18 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:
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- 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
- Not better accounted for by another ICHD-3 diagnosis.
- Participants experience 4-14 migraine days / month and fewer than 7 non-migraine headache days / month on average and overall, less than 15 days with headache (migraine or non-migraine) per month across the 3 months prior to screening.
- Participants on prophylactic migraine medication (non-CGRP) are permitted to remain on therapy if they have been on a stable dose for at least 3 months prior to screening visit, and the dose is not expected to change during the study.
- Participants have previous insufficient response and/or prior intolerance to at least one triptan or documented contraindication to the use of triptan.
- Insufficient response - Previous treatment with one or more triptan has yielded no, unsatisfactory or inconsistent therapeutic effect (eg, recurrent, incomplete relief of migraine related symptoms [including pain, nausea, photophobia, phonophobia etc] at 2 hours post dose, non-sustained relief of migraine related symptoms through 24 hours post dose, etc), after repeated dosing (≥2 attempts) at recommended dose level.
- Prior intolerance - treatment with triptan has been interrupted because of an adverse event that made continuation of the drug intolerable for the individual.
- -Prior triptan associated overuse headache
- -Arrhythmia associated with prior triptan use
- -Chest/throat/neck/jaw pain, tightness, pressure or heaviness associated with prior use of triptan
- -Gastrointestinal ischemia or peripheral vasospastic reaction associated with prior use of triptan
- Serotonin syndrome associated with prior triptan use
- Documented contraindication to triptans -
- Documented hypersensitivity to triptan
- Cardiovascular events, conditions and procedures considered contraindications to the use of triptan medications.
- Events: Myocardial infractions, prior cardiac arrest, transient ischemic attack, cerebrovascular accident (Intracerebral haemorrhage, intracranial haemorrhage, subarachnoid haemorrhage, ischemic stroke) ii. Conditions: Angina pectoris, coronary artery vasospasm, ischemic coronary artery disease, peripheral artery disease, ischemic bowel disease, cardiac conduction disorders (life threatening arrhythmia/heart block) iii. Procedure: Angioplasty, coronary artery bypass grafting, carotid endarterectomy 3) Uncontrolled hypertension
Who cannot join
- 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
- Suicidal ideation and behavior (one, or more, of the below is exclusionary):
- a positive response to item 1 or 2 of the C-SSRS within 30 days prior to Screening;
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- 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.
- Prior/Concurrent Clinical Study Experience:
- Participation in clinical trial with non-biological investigational agents or interventional treatments (last study visit occurring) within the 30 days or 5 half-lives of investigational drug (whichever is longer) prior to Baseline Visit. Participation in clinical trial with biological investigational agents (last study visit occurring) within 90 days or 5 half-lives (whichever is longer) prior to Baseline Visit. Participation in any other investigational clinical trial while participating in this clinical trial.
- Diagnostic Assessments:
- ANY of the following findings at the Screening Visit and laboratory tests as assessed by the study-specific laboratory:
- eGFR (using CKD-EPI-Scr-Scys Combined) <30 mL/min/1.73m²
- Total bilirubin >1.5 × ULN (may be repeated once, with fractionation, for confirmation during the Screening Phase, and direct bilirubin >ULN is exclusionary if Gilbert's syndrome is suspected)
- AST (SGOT) or ALT (SGPT) >2.0 × ULN
- Other Exclusion Criteria:
- Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
India7 sites, 7 recruiting
- Recruiting
BGS Global Institute of Medical Sciences
Bangalore, Karnataka, 560060
- Recruiting
Artemis Hospital
Gurugram, Haryana, 122001
- Not yet recruiting
Bangur Institute of Neurosciences, IPGME&R - SSKM Hospital
Kolkata, West Bengal, 700020
- Recruiting
Mallikatta Neuro Centre
Mangalore, Karnataka, 575002
- Recruiting
Chopda Medicare & Research Centre Pvt. Ltd: Magnum Heart Institute
Nashik, Maharashtra, 422005
- Recruiting
Bhaktivedanta Hospital & Research Institute
Thane, Maharashtra, 401107
- Recruiting
Visakha Institute Medical Sciences
Visakhapatnam, Andhra Pradesh, 530040
About this study
Official title: AN OPEN-LABEL MULTICENTER STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF RIMEGEPANT 75 MG ODT FOR ACUTE TREATMENT OF MIGRAINE IN ADULT PARTICIPANTS IN INDIA WITH PREVIOUS INSUFFICIENT RESPONSE TO TRIPTANS
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.
Read the detailed description
The primary objective of this study is to evaluate the safety and tolerability of rimegepant 75 mg ODT. The primary endpoints are Incidence of Treatment-emergent adverse events (TEAEs) and Incidence of Serious adverse events (SAEs)
This is a multicenter, single arm, open label phase IV study to evaluate the safety and tolerability of rimegepant 75 mg ODT for acute treatment of migraine with or without aura in adult migraine patients in India with a previous insufficient response to triptans, which includes: inadequate efficacy from treatment with triptans, intolerance to triptans, or contraindication(s) to triptans.
Approximately 60 participants will be enrolled in the study.
The participants who meet the inclusion exclusion criteria will be enrolled within 28 days of screening visit. The site staff will dispense the study medication ie, a single blister card containing one tablet of rimegepant 75 mg ODT to the participant to be taken for the treatment of subsequent migraine attack within 30 days of the baseline visit. Participants will be required to notify the site by a phone call in the event of a migraine attack and confirm whether the medication was taken. Participants will have a 12-hour window to contact the site following a migraine attack so that the call can be completed within the site's working hours. Following this, participants will receive a telephone call approximately 2 days after taking rimegepant 75 mg ODT, during which any AEs or SAEs will be evaluated. Participant satisfaction will be evaluated using TSQM-9 during post dose phone call. The participant will come for an EOS visit (28-35) days post-dose. Total duration of the study can go up to 93 days including, screening period = up to 28 days treatment window = up to 30 days follow up period = up to 35 days post dose (maximum total = 28 + 30 + 35 = up to 93 days)
- Conditions
- Acute Treatment of Migraine
- Being tested
- Rimegepant 75 mg ODT
- Keywords
- migraine, Rimegepant
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rimegepant 75 mg ODTDrug
Rimegepant 75 mg ODT (1 tablet) PRN at the time of migraine attack
| Study group | Role | What they receive |
|---|---|---|
| Rimegepant 75 mg ODT | Other | Rimegepant 75 mg ODT (1 tablet) PRN at the time of migraine attack Receives: Drug: Rimegepant 75 mg ODT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-emergent adverse events (TEAEs)
Measured: Up to 28 days
Incidence of Serious adverse events (SAEs)
Measured: up to 28 days
Secondary outcomes (2)
Incidence of clinically significant vital signs abnormalities
Measured: up to 28 days
Absolute score on treatment satisfaction questionnaire for medication (TSQM-9) subscales
Measured: 2-7 days after taking study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start24 Jul 2026
- Primary completion4 Jan 2028 (estimated)
- Study completion4 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Treatment of MigraineStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685769
- Sponsor's protocol ID
- C4951088
- Status last verified
- Oct 2026
- First submitted
- 29 Jun 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.