Randomized, Double-Blind, Placebo-Controlled, Multiple-Attack Study with an Open-Label Extension to Evaluate the Efficacy, Safety, Tolerability, and the Consistency of Effect of Atogepant for the Acute Treatment of Migraine (ECLIPSE)

Conditions

Migraine

Brief summary

Pain freedom (defined as a reduction in headache severity from moderate/severe at baseline [predose] to no pain) at 2 hours after the DB dose for the first attack

Detailed description

Absence of the MBS at 2 hours after the DB dose for the first attack (coprimary endpoint for China), Pain relief (defined as the reduction of a moderate/severe migraine headache at baseline [predose] to a mild headache or to no headache) at 2 hours after the DB dose for the first attack, Sustained pain relief from 2 to 24 hours (defined as pain relief at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a moderate/severe headache from 2 to 24 hours) after the DB dose for the first attack, Sustained pain relief from 2 to 48 hours after the DB dose for the first attack, Use of rescue medication within 24 hours after the DB dose for the first attack, Ability to function normally at 2 hours after the DB dose for the first attack, Sustained pain freedom from 2 to 24 hours (defined as pain freedom at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a mild/moderate/severe headache from 2 to 24 hours) after the DB dose for the first attack, Sustained pain freedom from 2 to 48 hours after the DB dose for the first attack, Absence of photophobia at 2 hours after the DB dose for the first attack, Absence of phonophobia at 2 hours after the DB dose for the first attack, Pain freedom at 8 hours after the DB dose for the first attack, Ability to function normally 8 hours after the DB dose for the first attack, Pain relief at 1 hour after the DB dose for the first attack, Absence of nausea at 2 hours after the DB dose for the first attack, Pain relief at 30 minutes after the DB dose for the first attack, Ability to function normally at 1 hour after the DB dose for the first attack

Related papers

No related papers found yet.

Interventions

DRUGPlacebo for atogepant tablets 60mg

DRUGAtogepant

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Pain freedom (defined as a reduction in headache severity from moderate/severe at baseline [predose] to no pain) at 2 hours after the DB dose for the first attack	—

Secondary

Measure	Time frame
Absence of the MBS at 2 hours after the DB dose for the first attack (coprimary endpoint for China), Pain relief (defined as the reduction of a moderate/severe migraine headache at baseline [predose] to a mild headache or to no headache) at 2 hours after the DB dose for the first attack, Sustained pain relief from 2 to 24 hours (defined as pain relief at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a moderate/severe headache from 2 to 24 hours) after the DB dose for the first attack, Sustained pain relief from 2 to 48 hours after the DB dose for the first attack, Use of rescue medication within 24 hours after the DB dose for the first attack, Ability to function normally at 2 hours after the DB dose for the first attack, Sustained pain freedom from 2 to 24 hours (defined as pain freedom at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a mild/moderate/severe headache from 2 to 24 hours) after the	—

Measure

Time frame

Absence of the MBS at 2 hours after the DB dose for the first attack (coprimary endpoint for China), Pain relief (defined as the reduction of a moderate/severe migraine headache at baseline [predose] to a mild headache or to no headache) at 2 hours after the DB dose for the first attack, Sustained pain relief from 2 to 24 hours (defined as pain relief at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a moderate/severe headache from 2 to 24 hours) after the DB dose for the first attack, Sustained pain relief from 2 to 48 hours after the DB dose for the first attack, Use of rescue medication within 24 hours after the DB dose for the first attack, Ability to function normally at 2 hours after the DB dose for the first attack, Sustained pain freedom from 2 to 24 hours (defined as pain freedom at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a mild/moderate/severe headache from 2 to 24 hours) after the

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Countries

Belgium, Czechia, Germany, Hungary, Italy, Poland, Portugal, Slovakia, Spain, Sweden

Outcome results

None listed