C4951063: An interventional efficacy and safety, Phase 3, double-blind, parallel group study to investigate intermittent prevention of Menstrual Migraine with Rimegepant compared with placebo in women participants 18 to 45 years of age

Conditions

Menstrual Migraine

Brief summary

Mean change from the OP in number of migraine days per 5-day PMP across each cycle of the DBT Phase.

Detailed description

Mean change from the OP in number of headache days per 5-day PMP across each cycle of the DBT Phase., Percentage of participants with ≥50% reduction from the OP in number of migraine days per 5-day PMP across each cycle of the DBT Phase (50% responder)., Mean change from the OP in number of acute migraine medication days per 5-day PMP across each cycle of the DBT Phase., Mean change from the OP in number of acute migraine-specific medication days per 5-day PMP across each cycle of the DBT Phase (based on eDiary response)., Mean change from the OP in number of migraine days with moderate-severe functional disability per 5-day PMP across each cycle of the DBT Phase., Mean change from the OP in number of moderate-severe headache days per 5-day PMP across each cycle of the DBT Phase., Mean change from the OP in number of moderate-severe migraine days per 5-day PMP across each cycle of the DBT Phase., Mean change from baseline in the MiCOAS (Migraine Clinical Outcome Assessment System) Cognition score at post-dosing (ie, 1 day after the 7-day dosing period) across each cycle of the DBT Phase., Mean change from the OP in monthly migraine days (per cycle, normalized to 28-days) across each cycle of the DBT Phase., Mean change from the OP in monthly headache days (per cycle, normalized to 28-days) across each cycle of the DBT Phase., Mean change from the OP in monthly acute migraine-specific medication days (per cycle, normalized to 28-days) across each cycle of the DBT Phase.

Related papers

No related papers found yet.

Interventions

DRUGVYDURA 75 mg oral lyophilisate

DRUGmatching placebo for 75 mg oral lyophilisate

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Mean change from the OP in number of migraine days per 5-day PMP across each cycle of the DBT Phase.	—

Secondary

Measure	Time frame
Mean change from the OP in number of headache days per 5-day PMP across each cycle of the DBT Phase., Percentage of participants with ≥50% reduction from the OP in number of migraine days per 5-day PMP across each cycle of the DBT Phase (50% responder)., Mean change from the OP in number of acute migraine medication days per 5-day PMP across each cycle of the DBT Phase., Mean change from the OP in number of acute migraine-specific medication days per 5-day PMP across each cycle of the DBT Phase (based on eDiary response)., Mean change from the OP in number of migraine days with moderate-severe functional disability per 5-day PMP across each cycle of the DBT Phase., Mean change from the OP in number of moderate-severe headache days per 5-day PMP across each cycle of the DBT Phase., Mean change from the OP in number of moderate-severe migraine days per 5-day PMP across each cycle of the DBT Phase., Mean change from baseline in the MiCOAS (Migraine Clinical Outcome Assessment System) Cogn	—

Measure

Time frame

Mean change from the OP in number of headache days per 5-day PMP across each cycle of the DBT Phase., Percentage of participants with ≥50% reduction from the OP in number of migraine days per 5-day PMP across each cycle of the DBT Phase (50% responder)., Mean change from the OP in number of acute migraine medication days per 5-day PMP across each cycle of the DBT Phase., Mean change from the OP in number of acute migraine-specific medication days per 5-day PMP across each cycle of the DBT Phase (based on eDiary response)., Mean change from the OP in number of migraine days with moderate-severe functional disability per 5-day PMP across each cycle of the DBT Phase., Mean change from the OP in number of moderate-severe headache days per 5-day PMP across each cycle of the DBT Phase., Mean change from the OP in number of moderate-severe migraine days per 5-day PMP across each cycle of the DBT Phase., Mean change from baseline in the MiCOAS (Migraine Clinical Outcome Assessment System) Cogn

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Countries

Denmark, Germany, Italy, Netherlands, Poland, Spain

Outcome results

None listed