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 |
|---|---|---|---|---|
| NCT02848326 | Migraine Disorders | Change From Baseline in Mean Monthly Migraine Days (Migraine/Probable Migraine Headache Days) Across the 12-Week Treatment Period Baseline (First 28 Days of Screening/Baseline Period) to Week 12 | Atogepant 10 mg QD | -4.00 migraine days per month (±0.32 Standard Error) |
| Atogepant 30 mg BID | -4.23 migraine days per month (±0.35 Standard Error) | |||
| Atogepant 30 mg QD | -3.76 migraine days per month (±0.23 Standard Error) | |||
| Atogepant 60 mg BID | -4.14 migraine days per month (±0.33 Standard Error) | |||
| Atogepant 60 mg QD | -3.55 migraine days per month (±0.23 Standard Error) | |||
| Placebo | -2.85 migraine days per month (±0.23 Standard Error) | |||
| NCT03700320 | — | Percentage of Participants With at Least 1 Treatment Emergent Adverse Event (TEAE) From first dose up to the end of study (median treatment of 52 weeks) + 4 weeks follow-up | Atogepant 60 mg | 67.0 percentage of participants |
| Oral SOC Migraine Preventive Medication | 78.6 percentage of participants | |||
| NCT03777059 | Migraine Disorders | Change From Baseline in Mean Monthly Migraine Days Across the 12-Week Treatment Period Baseline (Day -28 to Day -1) to Week 12 | Atogepant 10 mg | -3.69 migraine days per month (±0.210 Standard Error) |
| Atogepant 30 mg | -3.86 migraine days per month (±0.206 Standard Error) | |||
| Atogepant 60 mg | -4.20 migraine days per month (±0.206 Standard Error) | |||
| Placebo | -2.48 migraine days per month (±0.210 Standard Error) | |||
| NCT03855137 | — | Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in mITT Population Baseline to Week 12 | Atogepant 30 mg BID | -7.13 migraine days per month |
| Atogepant 60 mg QD | -7.27 migraine days per month | |||
| Placebo | -4.63 migraine days per month | |||
| NCT03855137 | — | Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in Off-Treatment Hypothetical Estimand Population Baseline to Week 12 | Atogepant 30 mg BID | -7.00 migraine days per month |
| Atogepant 60 mg QD | -7.19 migraine days per month | |||
| Placebo | -4.65 migraine days per month | |||
| NCT03939312 | Migraine Disorders | Percentage of Participants With at Least 1 Treatment-Emergent Adverse Event and Treatment-Emergent Serious Adverse Event (TEAEs/TESAEs) From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44) | Atogepant 60 mg | 62.5 percentage of participants |
| Atogepant 60 mg | 3.4 percentage of participants | |||
| NCT04437433 JPN ATO OLE | — | Percentage of Participants With at Least 1 Treatment-Emergent Adverse Event and Treatment-Emergent Serious Adverse Event (TEAEs/TESAEs) From first dose of study drug until 4 weeks following the last dose of study drug (up to 56 weeks) | Atogepant 60 mg Chronic Migraine | 88.4 percentage of participants |
| Atogepant 60 mg Chronic Migraine | 4.5 percentage of participants | |||
| Atogepant 60 mg Episodic Migraine | 0.0 percentage of participants | |||
| Atogepant 60 mg Episodic Migraine | 90.3 percentage of participants | |||
| NCT04740827 ELEVATE | — | Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in mITT Population Baseline to Week 12 | Atogepant 60 mg | -4.29 migraine days per month (±0.397 Standard Error) |
| Placebo | -1.86 migraine days per month (±0.389 Standard Error) | |||
| NCT04740827 ELEVATE | — | Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in OTHE Population Baseline to Week 12 | Atogepant 60 mg | -4.20 migraine days per month (±0.393 Standard Error) |
| Placebo | -1.85 migraine days per month (±0.388 Standard Error) | |||
| NCT04829747 | Migraine Disorders | Number of Participants With a Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Baseline of the study 3101-303-002 to 16 weeks | Atogepant | 0 Participants |
| NCT04829747 | Migraine Disorders | Number of Participants With Adverse Events Baseline of the study 3101-303-002 to 16 weeks | Atogepant | 1 Participants |
| NCT04829747 | Migraine Disorders | Number of Participants With Significant Change in Clinical Laboratory Determinations Baseline of the study 3101-303-002 to 16 weeks | Atogepant | 0 Participants |
| NCT04829747 | Migraine Disorders | Number of Participants With Significant Change in Electrocardiogram (ECG) Parameters Baseline of the study 3101-303-002 to 12 weeks | Atogepant | 0 Participants |
| NCT04829747 | Migraine Disorders | Number of Participants With Significant Change in Vital Sign Measurements Baseline of the study 3101-303-002 to 16 weeks | Atogepant | 0 Participants |