Safety and Efficacy of ZP-Zolmitriptan Intracutaneous Microneedle Systems for the Acute Treatment of Migraine
(Zotrip Trial)

Recruiting in Palo Alto (17 mi)

+35 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Zosano Pharma Corporation

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Donald Kellerman, Pharm.D.

Principal Investigator

Zosano Pharma Corporation

Eligibility Criteria

Inclusion Criteria

Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)

(i) unilateral location (ii) pulsating quality (iii) moderate or severe pain intensity (iv) aggravation by or causing avoidance of routine physical activity (e.g., walking or climbing stairs) c) During headache at least one of the following: (i) nausea and/or vomiting (ii) both photophobia and phonophobia

Migraine history during the 6-month period prior to the run-in period must include: 2-8 migraines per month and no more than 10 headache days per month

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