A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine (Progress)

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2020
INTERVENTION: Intervention name : Atogepant INN of the intervention : ‐ Dosage And administration of the intervention : Atogepant 30mg (Tablet, taken twice daly) Atogepant 60mg (Tablet, taken once daly) Control intervention name : Placebo INN of the control intervention : ‐ Dosage And administration of the control intervention : Placebo (Tablet, taken twice daily) CONDITION: Chronic Migraine PRIMARY OUTCOME: efficacy; Change from baseline in mean monthly migraine days across the treatment period SECONDARY OUTCOME: efficacy; ‐ Change from baseline in mean monthly headache days across the 12‐week treatment period; ‐ Change from baseline in mean monthly acute medication use days across the 12‐week treatment period; ‐ Proportion of participants with at least a 50% reduction in mean monthly migraine days across the 12‐week treatment period; ‐ Change from baseline in MSQ v2.1 Role Function‐Restrictive domain score at Week 12; ‐ Change from baseline in mean AIM‐D monthly functioning and activity impairment score across the 12‐week treatment period INCLUSION CRITERIA: ‐ At least a 1‐year history of CM consistent with a diagnosis according to the ICHD‐3, 2018 ‐ Age of the participant at the time of migraine onset < 50 years ‐ Confirmation of headache/migraine headache day frequency as follows: ‐ History of, on average, >= 15 headache days per month in the 3 months prior to Visit 1 in the opinion of the investigator AND ‐ >= 15 headache days during the 4‐week screening/baseline period per the electronic diary (eDiary) AND ‐ >= 8 days during the 4‐week screening/baseline period that qualify as being a migraine day per the eDiary ‐ Participants must be using a medically acceptable and effective method of birth control during the course of the entire study
Epistemonikos ID: 82f36016ddbb80b875e8a65452a043318ba14329
First added on: Aug 24, 2024