Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05248997 | Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for the Acute Treatment of Chronic Rhinosinusitis | PHASE3 | COMPLETED | 261 | — | — | Feb 17, 2022 | Apr 2, 2024 | Mar 26, 2025 | 33 | United States |
Facial pain/pressure/fullness was assessed using an NRS score ranging in integers from 0 to 10, with 0 being "no facial pain/pressure/fullness" and 10 being "worst imaginable facial pain/pressure/fullness." Higher scores signified worse condition.
| Arm | Type | Description |
|---|---|---|
| rimegepant 75 mg ODT | ACTIVE_COMPARATOR | One dose of rimegepant 75 mg ODT |
| Matching Placebo | ACTIVE_COMPARATOR | One dose of matching placebo |
| Name | Type | Description |
|---|---|---|
| rimegepant 75 mg ODT | DRUG | One dose of rimegepant 75 mg ODT |
| Matching placebo | DRUG | One dose of matching placebo |
Inclusion Criteria: * At least two episodes of facial pain/pressure/fullness of moderate or severe intensity on a 4-point rating scale (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) in the past 30 days prior to the Screening Visit. * Subject agrees to study-required medication restrictions and the ...