Trial Profile
Randomized, Double-blind, Multi-center, Parallel-group, Dose-ranging Comparison of the Safety and Efficacy of the ZP-Zolmitriptan Intracutaneous Microneedle Systems to Placebo for the Acute Treatment of Migraine
Status:
Completed
Phase of Trial:
Phase II/III
Latest Information Update: 11 Jun 2021
Price :
$35
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At a glance
- Drugs Zolmitriptan (Primary)
- Indications Migraine
- Focus Registrational; Therapeutic Use
- Acronyms ZOTRIP
- Sponsors Zosano Pharma
- 22 Apr 2021 Results assessing if M207 meets newly proposed criteria for early time-to-onset presented at the 73rd Annual Meeting of the American Academy of Neurology
- 22 Feb 2021 According to a Zosano Pharma media release, The company plans for resubmitting the NDA are based on the discussions between the company and the FDA and may be subject to change upon receipt of the FDA's comments to the proposed study protocol.
- 22 Feb 2021 According to a Zosano Pharma media release, the company has received the official Type A meeting minutes from the U.S. FDA. In a post-meeting comment, the FDA recommended a skin assessment on patients in the planned PK study to generate additional safety information. This assessment is included in the proposed study protocol, which has been submitted to FDA.