A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study with an Open-Label Extension to Evaluate the Efficacy, Safety, and Tolerability of Atogepant for the Preventive Treatment of Menstrual Migraine

Conditions

Menstrual Migraine

Brief summary

The primary endpoint is the change from baseline (CFB) in number of migraine days occurring during the perimenstrual period (PMP) averaged across 3 menstrual cycles during the double-blind (DB) period.

Detailed description

CFB in number of migraine days (with moderate or severe headache) during the PMP averaged across 3 menstrual cycles during the DB period, 50% or above reduction from baseline in the number of migraine days averaged across 3 PMPs during the DB period, CFB in number of acute medication use days during the PMP averaged across 3 menstrual cycles during the DB period, CFB in number of moderate or severe headache days during the PMP averaged across 3 menstrual cycles during the DB period, 100% reduction from baseline in the number of migraine days averaged across 3 PMPs during the DB period, No disability/mild impairment for 100% of PMP days (assessed by FDS) across 3 menstrual cycles during the DB period, CFB in number of headache days during the PMP averaged across 3 menstrual cycles during the DB period

Related papers

No related papers found yet.

Interventions

DRUGAtogepant

DRUGPlacebo for Atogepant

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the change from baseline (CFB) in number of migraine days occurring during the perimenstrual period (PMP) averaged across 3 menstrual cycles during the double-blind (DB) period.	—

Secondary

Measure	Time frame
CFB in number of migraine days (with moderate or severe headache) during the PMP averaged across 3 menstrual cycles during the DB period, 50% or above reduction from baseline in the number of migraine days averaged across 3 PMPs during the DB period, CFB in number of acute medication use days during the PMP averaged across 3 menstrual cycles during the DB period, CFB in number of moderate or severe headache days during the PMP averaged across 3 menstrual cycles during the DB period, 100% reduction from baseline in the number of migraine days averaged across 3 PMPs during the DB period, No disability/mild impairment for 100% of PMP days (assessed by FDS) across 3 menstrual cycles during the DB period, CFB in number of headache days during the PMP averaged across 3 menstrual cycles during the DB period	—

Measure

Time frame

CFB in number of migraine days (with moderate or severe headache) during the PMP averaged across 3 menstrual cycles during the DB period, 50% or above reduction from baseline in the number of migraine days averaged across 3 PMPs during the DB period, CFB in number of acute medication use days during the PMP averaged across 3 menstrual cycles during the DB period, CFB in number of moderate or severe headache days during the PMP averaged across 3 menstrual cycles during the DB period, 100% reduction from baseline in the number of migraine days averaged across 3 PMPs during the DB period, No disability/mild impairment for 100% of PMP days (assessed by FDS) across 3 menstrual cycles during the DB period, CFB in number of headache days during the PMP averaged across 3 menstrual cycles during the DB period

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Countries

Czechia, Germany, Hungary, Italy, Poland, Portugal, Spain

Outcome results

None listed

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study with an Open-Label Extension to Evaluate the Efficacy, Safety, and Tolerability of Atogepant for the Preventive Treatment of Menstrual Migraine​ ​