Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT03235479 | Migraine Disorders | Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose 2 hours post-dose | Placebo | 27.7 percentage of participants |
| Rimegepant 75 mg | 36.6 percentage of participants | |||
| NCT03235479 | Migraine Disorders | Percentage of Participants With Freedom From Pain at 2 Hours Post-dose 2 hours post-dose | Placebo | 14.2 percentage of participants |
| Rimegepant 75 mg | 19.2 percentage of participants | |||
| NCT03237845 | Migraine Disorders | Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose 2 Hours | Placebo | 25.2 Percentage of Participants |
| Rimegepant 75 mg | 37.6 Percentage of Participants | |||
| NCT03237845 | Migraine Disorders | Percentage of Participants With Freedom From Pain at 2 Hours Post-dose 2 Hours post-dose | Placebo | 12.0 Percentage of participants |
| Rimegepant 75 mg | 19.6 Percentage of participants | |||
| NCT03266588 | Migraine Disorders | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period PRN (2-8) and PRN (9-14) groups: Up to 52 weeks: Scheduled EOD + PRN group: Up to 12 weeks | PRN (2-8) Group | 0 Participants |
| PRN (2-8) Group | 0 Participants | |||
| PRN (2-8) Group | 4 Participants | |||
| PRN (2-8) Group | 3 Participants | |||
| PRN (2-8) Group | 0 Participants | |||
| PRN (2-8) Group | 1 Participants | |||
| PRN (2-8) Group | 0 Participants | |||
| PRN (2-8) Group | 3 Participants | |||
| PRN (2-8) Group | 1 Participants | |||
| PRN (2-8) Group | 2 Participants | |||
| PRN (2-8) Group | 0 Participants | |||
| PRN (2-8) Group | 10 Participants | |||
| PRN (2-8) Group | 0 Participants | |||
| PRN (2-8) Group | 0 Participants | |||
| PRN (2-8) Group | 0 Participants | |||
| PRN (2-8) Group | 4 Participants | |||
| PRN (2-8) Group | 0 Participants | |||
| PRN (2-8) Group | 0 Participants | |||
| PRN (2-8) Group | 2 Participants | |||
| PRN (2-8) Group | 31 Participants | |||
| PRN (2-8) Group | 10 Participants | |||
| PRN (2-8) Group | 0 Participants | |||
| PRN (2-8) Group | 1 Participants | |||
| PRN (2-8) Group | 1 Participants | |||
| PRN (2-8) Group | 1 Participants | |||
| PRN (2-8) Group | 16 Participants | |||
| PRN (2-8) Group | 0 Participants | |||
| PRN (2-8) Group | 0 Participants | |||
| PRN (2-8) Group | 0 Participants | |||
| PRN (2-8) Group | 0 Participants | |||
| PRN (2-8) Group | 0 Participants | |||
| PRN (9-14) Group | 1 Participants | |||
| PRN (9-14) Group | 0 Participants | |||
| PRN (9-14) Group | 0 Participants | |||
| PRN (9-14) Group | 15 Participants | |||
| PRN (9-14) Group | 2 Participants | |||
| PRN (9-14) Group | 0 Participants | |||
| PRN (9-14) Group | 0 Participants | |||
| PRN (9-14) Group | 1 Participants | |||
| PRN (9-14) Group | 2 Participants | |||
| PRN (9-14) Group | 0 Participants | |||
| PRN (9-14) Group | 2 Participants | |||
| PRN (9-14) Group | 0 Participants | |||
| PRN (9-14) Group | 0 Participants | |||
| PRN (9-14) Group | 0 Participants | |||
| PRN (9-14) Group | 0 Participants | |||
| PRN (9-14) Group | 0 Participants | |||
| PRN (9-14) Group | 0 Participants | |||
| PRN (9-14) Group | 0 Participants | |||
| PRN (9-14) Group | 10 Participants | |||
| PRN (9-14) Group | 0 Participants | |||
| PRN (9-14) Group | 0 Participants | |||
| PRN (9-14) Group | 1 Participants | |||
| PRN (9-14) Group | 1 Participants | |||
| PRN (9-14) Group | 0 Participants | |||
| PRN (9-14) Group | 1 Participants | |||
| PRN (9-14) Group | 0 Participants | |||
| PRN (9-14) Group | 0 Participants | |||
| PRN (9-14) Group | 0 Participants | |||
| PRN (9-14) Group | 0 Participants | |||
| PRN (9-14) Group | 2 Participants | |||
| PRN (9-14) Group | 0 Participants | |||
| Scheduled EOD + PRN Group | 0 Participants | |||
| Scheduled EOD + PRN Group | 3 Participants | |||
| Scheduled EOD + PRN Group | 0 Participants | |||
| Scheduled EOD + PRN Group | 0 Participants | |||
| Scheduled EOD + PRN Group | 0 Participants | |||
| Scheduled EOD + PRN Group | 0 Participants | |||
| Scheduled EOD + PRN Group | 0 Participants | |||
| Scheduled EOD + PRN Group | 0 Participants | |||
| Scheduled EOD + PRN Group | 0 Participants | |||
| Scheduled EOD + PRN Group | 0 Participants | |||
| Scheduled EOD + PRN Group | 1 Participants | |||
| Scheduled EOD + PRN Group | 2 Participants | |||
| Scheduled EOD + PRN Group | 0 Participants | |||
| Scheduled EOD + PRN Group | 0 Participants | |||
| Scheduled EOD + PRN Group | 0 Participants | |||
| Scheduled EOD + PRN Group | 0 Participants | |||
| Scheduled EOD + PRN Group | 0 Participants | |||
| Scheduled EOD + PRN Group | 0 Participants | |||
| Scheduled EOD + PRN Group | 0 Participants | |||
| Scheduled EOD + PRN Group | 0 Participants | |||
| Scheduled EOD + PRN Group | 0 Participants | |||
| Scheduled EOD + PRN Group | 0 Participants | |||
| Scheduled EOD + PRN Group | 1 Participants | |||
| Scheduled EOD + PRN Group | 0 Participants | |||
| Scheduled EOD + PRN Group | 0 Participants | |||
| Scheduled EOD + PRN Group | 0 Participants | |||
| Scheduled EOD + PRN Group | 0 Participants | |||
| Scheduled EOD + PRN Group | 0 Participants | |||
| Scheduled EOD + PRN Group | 0 Participants | |||
| Scheduled EOD + PRN Group | 0 Participants | |||
| Scheduled EOD + PRN Group | 3 Participants | |||
| NCT03266588 | Migraine Disorders | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks | PRN (2-8) Group | 72 Participants |
| PRN (2-8) Group | 108 Participants | |||
| PRN (2-8) Group | 51 Participants | |||
| PRN (2-8) Group | 664 Participants | |||
| PRN (2-8) Group | 24 Participants | |||
| PRN (2-8) Group | 28 Participants | |||
| PRN (2-8) Group | 1 Participants | |||
| PRN (2-8) Group | 30 Participants | |||
| PRN (2-8) Group | 26 Participants | |||
| PRN (2-8) Group | 57 Participants | |||
| PRN (2-8) Group | 19 Participants | |||
| PRN (2-8) Group | 53 Participants | |||
| PRN (2-8) Group | 1 Participants | |||
| PRN (2-8) Group | 56 Participants | |||
| PRN (9-14) Group | 16 Participants | |||
| PRN (9-14) Group | 0 Participants | |||
| PRN (9-14) Group | 0 Participants | |||
| PRN (9-14) Group | 17 Participants | |||
| PRN (9-14) Group | 28 Participants | |||
| PRN (9-14) Group | 315 Participants | |||
| PRN (9-14) Group | 13 Participants | |||
| PRN (9-14) Group | 19 Participants | |||
| PRN (9-14) Group | 21 Participants | |||
| PRN (9-14) Group | 41 Participants | |||
| PRN (9-14) Group | 9 Participants | |||
| PRN (9-14) Group | 38 Participants | |||
| PRN (9-14) Group | 16 Participants | |||
| PRN (9-14) Group | 28 Participants | |||
| Scheduled EOD + PRN Group | 109 Participants | |||
| Scheduled EOD + PRN Group | 8 Participants | |||
| Scheduled EOD + PRN Group | 7 Participants | |||
| Scheduled EOD + PRN Group | 9 Participants | |||
| Scheduled EOD + PRN Group | 0 Participants | |||
| Scheduled EOD + PRN Group | 4 Participants | |||
| Scheduled EOD + PRN Group | 2 Participants | |||
| Scheduled EOD + PRN Group | 7 Participants | |||
| Scheduled EOD + PRN Group | 8 Participants | |||
| Scheduled EOD + PRN Group | 5 Participants | |||
| Scheduled EOD + PRN Group | 2 Participants | |||
| Scheduled EOD + PRN Group | 12 Participants | |||
| Scheduled EOD + PRN Group | 0 Participants | |||
| Scheduled EOD + PRN Group | 3 Participants | |||
| NCT03461757 | Migraine Disorders | Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose 2 hours post-dose | Placebo | 26.8 percentage of participants |
| Rimegepant 75 mg ODT | 35.1 percentage of participants | |||
| NCT03461757 | Migraine Disorders | Percentage of Participants With Freedom From Pain at 2 Hours Post-dose 2 hours post-dose | Placebo | 10.9 percentage of participants |
| Rimegepant 75 mg ODT | 21.2 percentage of participants | |||
| NCT03732638 | Migraine Disorders | Change From Baseline in the Mean Number of Total Migraine Days Per Month in the Last 4 Weeks of the DBT Phase OP and Weeks 9 to 12 of the DBT phase | Placebo - Randomization Phase | -3.5 Total Migraine Days per Month |
| Rimegepant - Randomization Phase | -4.3 Total Migraine Days per Month | |||
| NCT04574362 | Migraine Disorders | Percentage of Participants Who Had Freedom From Most Bothersome Symptoms (MBS) at 2 Hours Post-dose 2 hours post-dose | Placebo | 35.8 Percentage of participants |
| Rimegepant 75 mg | 50.5 Percentage of participants | |||
| NCT04574362 | Migraine Disorders | Percentage of Participants Who Had Freedom From Pain at 2 Hours Post-dose 2 hours post-dose | Placebo | 10.7 Percentage of participants |
| Rimegepant 75 mg | 19.8 Percentage of participants | |||
| NCT05248997 | — | Change From Baseline in Facial Pain/Pressure/Fullness on NRS at 2 Hours Post-Dose Baseline, 2 hours post-dose | Placebo | -2.61 Scores on a scale |
| Rimegepant 75 mg | -2.70 Scores on a scale | |||
| NCT05262517 | Temporomandibular Joint Disorders | SPID From Baseline to 24-Hours Post-dose (SPID-24) Baseline (0 hours) to 24-hours post-dose | Placebo | -109.79 Unit on a scale |
| Rimegepant (BHV3000) | -104.66 Unit on a scale | |||
| NCT05262517 | Temporomandibular Joint Disorders | Sum of Pain Intensity Difference (SPID) From Baseline to 2-Hours Post-dose (SPID-2) Baseline (0 hours) to 2-hours post-dose | Placebo | -3.67 Units on a scale |
| Rimegepant (BHV3000) | -3.82 Units on a scale | |||
| NCT05371652 | Migraine Disorders | Follow-up Safety Period: Number of Participants With AEs Leading to Study Drug Discontinuation From Week 52 to Week 54 of the follow-up safety period | Rimegepant 75 mg ODT | 0 Participants |
| NCT05371652 | Migraine Disorders | Follow-up Safety Period: Number of Participants With Chemistry Test Abnormalities From Week 52 to Week 54 of the follow-up safety period | Rimegepant 75 mg ODT | 0 Participants |
| Rimegepant 75 mg ODT | 0 Participants | |||
| Rimegepant 75 mg ODT | 0 Participants | |||
| Rimegepant 75 mg ODT | 1 Participants | |||
| Rimegepant 75 mg ODT | 0 Participants | |||
| Rimegepant 75 mg ODT | 0 Participants | |||
| Rimegepant 75 mg ODT | 0 Participants | |||
| Rimegepant 75 mg ODT | 0 Participants | |||
| Rimegepant 75 mg ODT | 0 Participants | |||
| Rimegepant 75 mg ODT | 0 Participants | |||
| Rimegepant 75 mg ODT | 0 Participants | |||
| Rimegepant 75 mg ODT | 0 Participants | |||
| Rimegepant 75 mg ODT | 0 Participants | |||
| Rimegepant 75 mg ODT | 0 Participants | |||
| Rimegepant 75 mg ODT | 0 Participants | |||
| Rimegepant 75 mg ODT | 0 Participants | |||
| NCT05371652 | Migraine Disorders | Follow-up Safety Period: Number of Participants With ECG Abnormalities From Week 52 to Week 54 of the follow-up safety period | Rimegepant 75 mg ODT | 209 Participants |
| Rimegepant 75 mg ODT | 2 Participants | |||
| Rimegepant 75 mg ODT | 2 Participants | |||
| Rimegepant 75 mg ODT | 0 Participants | |||
| NCT05371652 | Migraine Disorders | Follow-up Safety Period: Number of Participants With Hematology Test Abnormalities From Week 52 to Week 54 of the follow-up safety period | Rimegepant 75 mg ODT | 0 Participants |
| Rimegepant 75 mg ODT | 0 Participants | |||
| Rimegepant 75 mg ODT | 0 Participants | |||
| Rimegepant 75 mg ODT | 0 Participants | |||
| Rimegepant 75 mg ODT | 0 Participants | |||
| Rimegepant 75 mg ODT | 1 Participants | |||
| Rimegepant 75 mg ODT | 0 Participants | |||
| Rimegepant 75 mg ODT | 0 Participants | |||
| NCT05371652 | Migraine Disorders | Follow-up Safety Period: Number of Participants With SAEs From Week 52 to Week 54 of the follow-up safety period | Rimegepant 75 mg ODT | 0 Participants |
| NCT05371652 | Migraine Disorders | Follow-up Safety Period: Number of Participants With TEAEs From Week 52 to Week 54 of the follow-up safety period | Rimegepant 75 mg ODT | 24 Participants |
| NCT05371652 | Migraine Disorders | Follow-up Safety Period: Number of Participants With Vital Signs Abnormalities. From Week 52 to Week 54 of the follow-up safety period | Rimegepant 75 mg ODT | 0 Participants |
| Rimegepant 75 mg ODT | 0 Participants | |||
| Rimegepant 75 mg ODT | 0 Participants | |||
| Rimegepant 75 mg ODT | 5 Participants | |||
| Rimegepant 75 mg ODT | 1 Participants | |||
| Rimegepant 75 mg ODT | 1 Participants | |||
| NCT05371652 | Migraine Disorders | Treatment Safety Period: Number of Participants With AEs Leading to Study Drug Discontinuation From Day 1 of study treatment up to Week 52 of the treatment safety period | Rimegepant 75 mg ODT | 1 Participants |
| NCT05371652 | Migraine Disorders | Treatment Safety Period: Number of Participants With Chemistry Test Abnormalities From Day 1 of study treatment up to Week 52 of the treatment safety period | Rimegepant 75 mg ODT | 0 Participants |
| Rimegepant 75 mg ODT | 0 Participants | |||
| Rimegepant 75 mg ODT | 4 Participants | |||
| Rimegepant 75 mg ODT | 1 Participants | |||
| Rimegepant 75 mg ODT | 0 Participants | |||
| Rimegepant 75 mg ODT | 0 Participants | |||
| Rimegepant 75 mg ODT | 0 Participants | |||
| Rimegepant 75 mg ODT | 0 Participants | |||
| Rimegepant 75 mg ODT | 2 Participants | |||
| Rimegepant 75 mg ODT | 0 Participants | |||
| Rimegepant 75 mg ODT | 0 Participants | |||
| Rimegepant 75 mg ODT | 1 Participants | |||
| Rimegepant 75 mg ODT | 0 Participants | |||
| Rimegepant 75 mg ODT | 0 Participants | |||
| Rimegepant 75 mg ODT | 0 Participants | |||
| Rimegepant 75 mg ODT | 0 Participants | |||
| NCT05371652 | Migraine Disorders | Treatment Safety Period: Number of Participants With Electrocardiogram (ECG) Abnormalities From Day 1 of study treatment up to Week 52 of the treatment safety period | Rimegepant 75 mg ODT | 6 Participants |
| Rimegepant 75 mg ODT | 225 Participants | |||
| Rimegepant 75 mg ODT | 0 Participants | |||
| Rimegepant 75 mg ODT | 0 Participants | |||
| NCT05371652 | Migraine Disorders | Treatment Safety Period: Number of Participants With Hematology Test Abnormalities From Day 1 of study treatment up to Week 52 of the treatment safety period | Rimegepant 75 mg ODT | 0 Participants |
| Rimegepant 75 mg ODT | 0 Participants | |||
| Rimegepant 75 mg ODT | 1 Participants | |||
| Rimegepant 75 mg ODT | 1 Participants | |||
| Rimegepant 75 mg ODT | 0 Participants | |||
| Rimegepant 75 mg ODT | 1 Participants | |||
| Rimegepant 75 mg ODT | 0 Participants | |||
| Rimegepant 75 mg ODT | 1 Participants | |||
| NCT05371652 | Migraine Disorders | Treatment Safety Period: Number of Participants With Serious Adverse Events (SAEs) From Day 1 of study treatment up to Week 52 of the treatment safety period | Rimegepant 75 mg ODT | 7 Participants |
| NCT05371652 | Migraine Disorders | Treatment Safety Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs) From Day 1 of study treatment up to Week 52 of the treatment safety period | Rimegepant 75 mg ODT | 203 Participants |
| NCT05371652 | Migraine Disorders | Treatment Safety Period: Number of Participants With Vital Signs Abnormalities From Day 1 of study treatment up to Week 52 of the treatment safety period | Rimegepant 75 mg ODT | 1 Participants |
| Rimegepant 75 mg ODT | 0 Participants | |||
| Rimegepant 75 mg ODT | 0 Participants | |||
| Rimegepant 75 mg ODT | 12 Participants | |||
| Rimegepant 75 mg ODT | 17 Participants | |||
| Rimegepant 75 mg ODT | 9 Participants | |||
| NCT05399459 | Migraine Disorders | Percentage of Participants Who Had Freedom From Pain at 2 Hours Post-Dose 2 hours post-dose | Placebo | 13.0 Percentage of participants |
| Rimegepant 25 mg | 21.0 Percentage of participants | |||
| Rimegepant 75 mg | 32.4 Percentage of participants | |||
| NCT05399485 | Migraine Disorders | Mean Change From Baseline in Number of Migraine Days Per Month From Week 9 to 12 of the Double-Blind Treatment (DBT) Phase Baseline, Week 9 to Week 12 of the DBT phase | Placebo | -1.4 Days/month |
| Rimegepant | -2.4 Days/month |