An Open-Label Multicenter Study to Evaluate the Safety and Tolerability of Rimegepant 75 mg ODT for Acute Treatment of Migraine in Adult Participants in India With Previous Insufficient Response to Triptans - NIL

Pfizer Limited0 个研究点目标入组 60 人开始时间: 2026年7月24日最近更新: 2026年8月3日

试验速览

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•18 years of age or older who meet the reproductive criteria
•Participant has at least a 1-year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders including -
•a. At least 5 attacks fulfilling inclusion criteria
•b. Not better accounted for by another ICHD-3 diagnosis
•Participants experience 4-14 migraine days or month and fewer than 7 non-migraine headache days or month on average and overall, less than 15 days with headache (migraine or non-migraine) per month across the 3 months prior to screening.
•Participants on prophylactic migraine medication (non-CGRP) are permitted to remain on therapy as per specified conditions
•Participants have previous insufficient response and/or prior intolerance to at least one triptan or documented contraindication to the use of triptan.

•Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator s judgment, make the participant inappropriate for the study.
•Any of the following -
•History of any trigeminal autonomic cephalalgia
•Active chronic pain syndrome (examples as per exclusion criteria).; Other pain syndromes, dementia, or significant neurological disorders that, in the Investigator s opinion, interfere with study assessments of safety.

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