NCT02745392

Safety and Efficacy of ZP-Zolmitriptan Intracutaneous Microneedle Systems for the Acute Treatment of Migraine

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: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 365 (actual)
• Sponsor: Zosano Pharma Corporation · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Migraine

Interventions

Type	Name	Description
DRUG	ZP-Zolmitriptan	ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system
DRUG	Placebo	Placebo patch(es) to match ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system (one or two patches)

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2016-04-20
• Last updated: 2018-03-13
• Results posted: 2018-02-14

Locations

36 sites across 1 country: United States