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Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults With History of Inadequate Response to Oral Preventive Medications
Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults With History of Inadequate Response to Oral Preventive Medications

NCT05518123

CompletedPhase 4

Sponsor: Pfizer

Conditions: Migraine

Interventions: Rimegepant, Placebo

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

This study is being conducted to evaluate the efficacy and tolerability of rimegepant for migraine prophylaxis in adults with a history of inadequate response to oral preventive medications

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

1. Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age.
2. Migraine attacks, on average, lasting about 4 - 72 hours, if untreated.
3. 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).
4. Less than15 headache days (migraine or non-migraine) per month in each of the 3-months prior to the Screening Visit and throughout the Screening Phase.
5. Subjects must be able to distinguish migraine attacks from tension/cluster headaches. Prior inadequate response, within 10 years of the Screening Visit, to agents across 2-4 categories of recognized, orally-administered, migraine-preventive medications where at least one example of prior inadequate response is due to lack of efficacy or prior intolerance (not contraindication).

Exclusion Criteria:

1. History of cluster headaches, basilar migraine (migraine with brainstem aura), or hemiplegic migraine.
2. Current medication overuse headaches.
3. 15 or more headache days (migraine or non-migraine) per month in any of the 3-months prior to the Screening Visit or during the first 28- days of the Observation Phase.
4. Inadequate response (due to lack of efficacy, prior intolerance, or contraindication) to agents across \> 4 categories of recognized, orally administered, migraine-preventive medications.
5. Active chronic pain syndrome (such as fibromyalgia, chronic pelvic pain, complex regional pain syndrome \[CRPS\]).
6. 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 (111)
  • Los Angeles, California, United States
  • Sherman Oaks, California, United States
  • Stamford, Connecticut, United States
  • Edgewater, Florida, United States
  • Lake City, Florida, United States
  • Miami, Florida, United States
  • Ocoee, Florida, United States
  • Ormond Beach, Florida, United States
  • Boston, Massachusetts, United States
  • Marlborough, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Rochester Hills, Michigan, United States
  • Springfield, Missouri, United States
  • Weldon Spring, Missouri, United States
  • Las Vegas, Nevada, United States
  • Albuquerque, New Mexico, United States
  • North Massapequa, New York, United States
  • Greensboro, North Carolina, United States
  • Anderson, South Carolina, United States
  • Knoxville, Tennessee, United States
  • Lake Jackson, Texas, United States
  • Tomball, Texas, United States
  • Bellevue, Washington, United States
  • Sippy Downs, Queensland, Australia
  • Innsbruck, Tyrol, Austria
  • Klagenfurt, Austria
  • Jette, Brussels Capital, Belgium
  • Antwerp, Belgium
  • Bruges, Belgium
  • Hasselt, Belgium
  • + 81 more on CT.gov