Last updated 31 days ago

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

600 patients around the world

Available in Spain, Mexico, United States

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). Rimegepant will be further evaluated in this population with as needed use in a 12-week, open-label extension study.

Pfizer

4Research 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 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

: History of cluster headache, basilar migraine, or hemiplegic migraine
Current medication overuse headaches
Headaches occurring 15 or more days per month (migraine or non-migraine) in any of the 3 months prior to the Screening Visit
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

Av Independencia 2130, Trojes de Alonso, Aguascalientes

Clinstile S.A de C.V.

Durango 325, Roma Norte, Ciudad de México

Clinical Research Institute S.C.

Blvd. Manuel Ávila Camacho 1994, Colonia San Lucas Tepetlacalco, Tlalnepantla de Baz, Ciudad de México

Unidad de Investigación en Salud de Chihuahua S.C

Av. Renato Leduc No.151, Interior 4 Col. Toriello Guerra

SponsorPfizer

Conditions

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT05509400