Health Condition 1: G998- Other specified disorders of nervous system in diseases classified elsewhere
Conditions
Interventions
Intervention1: Rimegepant: A single dose of rimegepant 75 mg at the time of migraine
attack
Control Intervention1: Not Applicable, Open Lable - Single Arm Study: Not Applicable
Sponsors
Pfizer Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. 18 years of age or older who meet the reproductive criteria 2. 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 3. 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. 4. Participants on prophylactic migraine medication (non-CGRP) are permitted to remain on therapy as per specified conditions 5. Participants have previous insufficient response and/or prior intolerance to at least one triptan or documented contraindication to the use of triptan.
Exclusion criteria
Exclusion criteria: 1. 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. 2. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of rimegepant 75 mg oral disintegrating tabletTimepoint: Study duration 13 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety & tolerability of rimegepant 75 mg ODT in terms of changes in vital signsTimepoint: Incidence of clinically significant vital signs abnormalities during study in 13 weeks;To evaluate efficacy of rimegepant 75 mg ODTTimepoint: Absolute score on treatment satisfaction questionnaire for medication during study in 13 weeks subscales | — |
Countries
India
Contacts
Public ContactDr Seema Pai
Pfizer Limited
Outcome results
None listed