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

NCT05509400

CompletedPhase 4

Sponsor: Pfizer

Conditions: Migraine

Interventions: Rimegepant, Placebo, Rimegepant

Countries: United States, Australia, Austria, Belgium, Canada, Denmark, Finland, France

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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:

-Target Disease Exclusion:

1. History of cluster headache, basilar migraine, or hemiplegic migraine
2. Current medication overuse headaches
3. Headaches occurring 15 or more days per month (migraine or non-migraine) in any of the 3 months prior to the Screening Visit
4. Active chronic pain syndrome (such as fibromyalgia, chronic pelvic pain, complex regional pain syndrome \[CRPS\])
5. 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
Locations (93)
  • Los Angeles, California, United States
  • Stamford, Connecticut, United States
  • Lake City, Florida, United States
  • Ocoee, Florida, United States
  • Ormond Beach, Florida, United States
  • Sandy Springs, Georgia, United States
  • Overland Park, Kansas, United States
  • New Orleans, Louisiana, United States
  • Boston, Massachusetts, United States
  • Marlborough, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Rochester Hills, Michigan, United States
  • Southfield, Michigan, United States
  • Springfield, Missouri, United States
  • Weldon Spring, Missouri, United States
  • Brooklyn, New York, United States
  • New York, New York, United States
  • The Bronx, New York, United States
  • Greensboro, North Carolina, United States
  • Anderson, South Carolina, United States
  • Lake Jackson, Texas, United States
  • Tomball, Texas, United States
  • Bellevue, Washington, United States
  • Sippy Downs, Queensland, Australia
  • Melbourne, Victoria, Australia
  • Klagenfurt, Carinthia, Austria
  • Innsbruck, Tyrol, Austria
  • Saint-Nicolas, Liège, Belgium
  • Antwerp, Belgium
  • Brussels, Belgium
  • + 63 more on CT.gov