Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ZNS · 1 trial · 1 indication
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 | 13 | PHASE3 | Atogepant |
| Pfizer Inc. | PFE | 9 | PHASE3 | Rimegepant |
| Eli Lilly and Company | LLY | 2 | PHASE3 | Galcanezumab |
| Amgen Inc. | AMGN | 2 | PHASE3 | Erenumab Dose 1 |
| Ki Health Partners. LLC | RVNC | 1 | - | Daxibotulinumtonix A |
ZNS is an investigational small molecule being developed for the acute treatment of migraine. It is currently in Phase 3 clinical development, though the specific trial for ZNS has been completed. ZNS is not approved and remains under investigation for this use.
ZNS is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca is responsible for the clinical development of ZNS for the treatment of migraine.
ZNS is in Phase 3 clinical development for migraine. The Phase 3 trial has been completed, but ZNS remains investigational and has not been approved for any use. It is still in clinical development as a potential treatment for migraine.
ZNS has one clinical trial, identified as NCT03275922, which is a Phase 3 study titled 'Efficacy & Safety Of Zomig Nasal Spray For Acute Migraine Treatment In Subjects 6 To 11 Years, With OLE.' The trial enrolled 374 participants in the United States and has been completed.
ZNS is associated with the name Zomig, as indicated by the clinical trial title referencing 'Zomig Nasal Spray.' ZNS is being studied as a nasal spray formulation for acute migraine treatment in children aged 6 to 11 years.