Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-29 @ 4:16 PM
Study NCT ID:
NCT02745392
Status:
COMPLETED
Last Update Posted:
2018-03-13
First Post:
2016-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of ZP-Zolmitriptan Intracutaneous Microneedle Systems for the Acute Treatment of Migraine
Sponsor:
Zosano Pharma Corporation
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Zotrip
Brief Summary:
This is a randomized, double-blind, multi-center, parallel-group study designed to compare the safety and efficacy of a range of doses of ZP-Zolmitriptan intracutaneous microneedle systems to placebo.
Detailed Description:
This is a randomized, double-blind, multi-center, parallel group study designed to compare the safety and efficacy of a range of doses of ZP-Zolmitriptan intracutaneous microneedle systems to placebo. Subjects who have consented and meet the entry criteria will be randomized to one of four blinded treatment groups. There will be a screening period of up to 1 week, followed by a run-in period to record migraine activity. The run-in period is to determine eligibility for randomization, and is planned to be 4 weeks in duration but may be extended up to an additional 4 weeks to accommodate scheduling. Qualified subjects will randomize to the double-blind treatment period at Day 0 and will have up to 8 weeks to confirm and treat a qualifying migraine. Using the eDiary to confirm they are experiencing a qualified migraine, subjects will self-administer the patch or patches and continue to respond to questions in the eDiary for 48 hours post treatment administration.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: