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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05989048 | A Study to Learn About Zavegepant as the Acute Treatment of Migraine in Asian Adults | PHASE3 | COMPLETED | 1,414 | — | — | Nov 29, 2023 | May 30, 2025 | May 22, 2026 | 61 | China, South Korea +1 |
| NCT04571060 | Randomized Trial in Adult Participants With Acute Migraines | PHASE3 | COMPLETED | 1,978 | — | — | Oct 27, 2020 | Oct 22, 2021 | Apr 24, 2023 | 94 | United States |
| NCT03872453 | Acute Treatment Trial in Adult Subjects With Migraines | PHASE2 | COMPLETED | 2,154 | — | — | Mar 25, 2019 | Nov 11, 2019 | Sep 25, 2023 | 82 | United States |
Pain freedom was defined as pain intensity being none at the specified time point. Participants recorded their headache pain intensity using 4-point numeric rating scale (0= none, 1= mild, 2= moderate, 3= severe).
MBS was selected from nausea, phonophobia or photophobia before dosing by the participants. In this outcome measure, percentage of participants who recorded an MBS (present) before dosing and did not have the MBS (absent) at the time of evaluation (i.e., 2 hours post-dose) were reported.
Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the electronic clinical outcome assessment (eCOA) handheld device. Pain freedom was defined as pain level of none post-dose.
| Arm | Type | Description |
|---|---|---|
| Zavegepant | EXPERIMENTAL | Zavegepant intranasal 10 mg |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Zavegepant 5 mg | EXPERIMENTAL | Participants administered a single intranasal dose of zavegepant 5 mg on occurrence of migraine that reached moderate or severe intensity within 45 days after randomization. The dose was administered using Aptar Unidose System (UDS) liquid spray device. |
| Zavegepant 10 mg | EXPERIMENTAL | Participants administered a single intranasal dose of zavegepant 10 mg on occurrence of migraine that reached moderate or severe intensity within 45 days after randomization. The dose was administered using Aptar UDS liquid spray device. |
| Zavegepant 20 mg | EXPERIMENTAL | Participants administered a single intranasal dose of zavegepant 20 mg on occurrence of migraine that reached moderate or severe intensity within 45 days after randomization. The dose was administered using Aptar UDS liquid spray device. |
| Name | Type | Description |
|---|---|---|
| Zavegepant | DRUG | The participants will receive single active dose sufficient to treat 1 migraine headache of moderate or severe intensity within Treatment Phase. |
| Placebo | DRUG | Single dose of matching placebo taken within Treatment Phase. |
| Zavegepant matching placebo | DRUG | A single dose of placebo matched to zavegepant |
| Intranasal Aptar Pharma Unit Dose System | DEVICE | A single-dose intranasal device |
Inclusion Criteria: * Asian participants aged 18 years or older at screening. * Participants with minimum 1 year history of migraine (with or without aura) prior to the Screening Visit, consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, inc...
| 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 |