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C4951012 - BHV3000-407: A Phase 4, Randomized, Double-blind, Placebo controlled Study to Evaluate the Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults with a History of Inadequate Response to Oral Preventive Medications

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513270-21-00
Acronym
C4951012/BHV3000-407
Enrollment
470
Registered
2024-08-02
Start date
2023-03-14
Completion date
2025-07-08
Last updated
2025-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

migraine headaches with or without aura

Brief summary

Mean change from the Observation Phase in the number of migraine days per month over the entire double-blind treatment (DBT) Phase.

Detailed description

Proportion of subjects with ≥ 50% reduction from the Observation Phase in the number of migraine days of moderate or severe headache pain intensity per month over the entire DBT Phase (Weeks 1 to 12)., Mean change from the Observation Phase in the number of migraine days per month in the first 4 weeks (Weeks 1 to 4) of the DBT Phase., Mean change from the Observation Phase in the number of migraine days per month in the last 4 weeks (Weeks 9 to 12) of the DBT Phase., Mean change from baseline in the MSQ restrictive role function domain score at Week 12 of the DBT Phase., Mean change from baseline in the MIBS score at Week 12 of the DBT Phase.

Interventions

Sponsors

Pfizer Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Mean change from the Observation Phase in the number of migraine days per month over the entire double-blind treatment (DBT) Phase.

Secondary

MeasureTime frame
Proportion of subjects with ≥ 50% reduction from the Observation Phase in the number of migraine days of moderate or severe headache pain intensity per month over the entire DBT Phase (Weeks 1 to 12)., Mean change from the Observation Phase in the number of migraine days per month in the first 4 weeks (Weeks 1 to 4) of the DBT Phase., Mean change from the Observation Phase in the number of migraine days per month in the last 4 weeks (Weeks 9 to 12) of the DBT Phase., Mean change from baseline in the MSQ restrictive role function domain score at Week 12 of the DBT Phase., Mean change from baseline in the MIBS score at Week 12 of the DBT Phase.

Countries

Austria, Belgium, Denmark, Finland, Germany, Italy, Poland, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026