| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06603623 | Efficacy and Safety Trial of BHV-2100 for the Acute Treatment of Migraine | PHASE2 | COMPLETED | 647 | — | — | Oct 10, 2024 | Mar 28, 2025 | Feb 25, 2026 | 60 | United States |
Pain levels are assessed on a 4-point scale (none, mild, moderate, severe) using the electronic diary (eDiary). Pain freedom is defined as pain level of none. Coprimary endpoints will be tested hierarachically by dose
MBS is reported as nausea, photophobia, or phonophobia at migraine onset using the eDiary. Symptom status (absent, present) is assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Freedom from MBS is defined as MBS reported at onset that was absent post-dose. Coprimary endpoints will be tested hierarachically by dose
| Arm | Type | Description |
|---|---|---|
| BHV-2100 75 mg | EXPERIMENTAL | - |
| BHV-2100 150 mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| BHV-2100 | DRUG | BHV-2100 75mg |
| Placebo | DRUG | matching placebo |
Key Inclusion Criteria: Participants with at least 1 year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition,19 including the following: 1. 2-8 migraine headache attacks of moderate or severe inten...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 15 | PHASE3 | Atogepant, Topiramate, Ubrogepant, MEDI0618 |
| Pfizer Inc. | PFE | 9 | PHASE3 | Rimegepant, Rimegepant/BHV3000, Zavegepant, Various, Rimegepant for acute migraine treatment |
| Eli Lilly and Company | LLY | 2 | PHASE3 | Galcanezumab |
| Amgen Inc. | AMGN | 2 | PHASE3 | Erenumab Dose 1, erenumab-aooe |
| Ki Health Partners. LLC | RVNC | 1 | — | Daxibotulinumtonix A |