Last updated 31 days ago
Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults With History of Inadequate Response to Oral Preventive Medications
600 patients around the world
Available in Spain, Mexico, United States
Pfizer
5Research sites
600Patients around the world
This study is for people with
Migraine
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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 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.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).
- History of cluster headaches, basilar migraine (migraine with brainstem aura), or hemiplegic migraine.Current medication overuse headaches.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 28- day Observation Phase.Inadequate response (due to lack of efficacy, prior intolerance, or contraindication) to agents across > 4 categories of recognized, orally administered, migraine-preventive medications.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 or efficacy.
Sites
Centro de Investigación Médica Aguascalientes - CIMA
Clinstile S.A de C.V.
Clinical Research Institute S.C.
Medical Care & Research SA de CV
Unidad de Investigación en Salud de Chihuahua S.C
SponsorPfizer
Conditions
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05518123
