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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03275922 | Efficacy & Safety Of Zomig Nasal Spray For Acute Migraine Treatment In Subjects 6 To 11 Years, With OLE | PHASE3 | COMPLETED | 374 | — | — | Nov 27, 2017 | Sep 28, 2020 | Jan 11, 2021 | 47 | United States |
Headache pain intensity is assessed by the subjects immediately prior to treatment and 2 hours post-dose using a 4-point headache pain intensity scale (severe = 3, moderate = 2, mild = 1, or none = 0).
| Arm | Type | Description |
|---|---|---|
| Run-in - ZNS - Placebo - OLE | OTHER | After Run-in period, subjects will be randomized to ZNS followed by placebo ZNS. Upon successful completion of Part 1, subjects may enroll into OLE (Part 2). |
| Run-in - Placebo - ZNS - OLE | OTHER | After Run-in period, subjects will be randomized to placebo ZNS followed by ZNS. Upon successful completion of Part 1, subjects may enroll into OLE (Part 2). |
| Name | Type | Description |
|---|---|---|
| Placebo ZNS | DRUG | Placebo Zolmitriptan Nasal Spray |
| ZNS | DRUG | Zolmitriptan Nasal Spray |
Inclusion Criteria 1. Parent or legal guardian is able to provide written informed consent and subject is able to provide assent. 2. Subjects ages 6 to 11 years throughout the double-blind portion of the studyAn established diagnosis of migraine 3. By history, average migraine frequency of ≥ 2 atta...
| 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 |