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RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Rimegepant for Preventive Treatment of Migraine

Rimegepant is a calcitonin gene-related peptide (CGRP) receptor antagonist approved for the acute treatment of migraine attacks in adults and for the preventive treatment of episodic migraine in adults when administered every other day. This study evaluates once daily rimegepant for the preventive treatment of chronic migraine.

Official registry: https://clinicaltrials.gov/study/NCT07729462 · Pfizer · enrollment listed as 400

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Rimegepant, or Placebo. The registry lists allocation as randomized. Rimegepant is a calcitonin gene-related peptide (CGRP) receptor antagonist approved for the acute treatment of migraine attacks in adults and for the preventive treatment of episodic migraine in adults when administered every other day.

They plan to enroll about 400 people at 21 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, RANDOMIZED, 2-ARM STUDY TO INVESTIGATE THE PREVENTION OF CHRONIC MIGRAINE WITH RIMEGEPANT COMPARED WITH PLACEBO IN PARTICIPANTS 18 YEARS OF AGE OR OLDER

Interventions: Rimegepant, Placebo

Primary outcome (registry wording): Change From Observation Phase in Monthly Migraine Days (MMDs) Over the Entire Double-Blind Treatment Phase

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Male or female participants ≥18 years of age
  • Diagnosis of chronic migraine, with or without aura, according to International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria
  • History of migraine for at least 1 year before screening
  • Migraine onset before 50 years of age and chronic migraine onset before 65 years of age
  • Migraine attacks lasting 4 to 72 hours when untreated or unsuccessfully treated
  • During the 3 months prior to screening, an average of:
  • ≥15 monthly headache days (MHDs),

Public study contact (from the registry)

Pfizer CT.gov Call Center

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

21 listed

+ 2 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07729462 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07729462?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07729462?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary