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

NCT02745392 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 365

Last updated 2018-03-13

Study results available
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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.

Conditions

  • Acute Migraine

Interventions

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)

Sponsors & Collaborators

  • Zosano Pharma Corporation

    lead INDUSTRY

Principal Investigators

  • Donald Kellerman, Pharm.D. · Zosano Pharma Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02745392 on ClinicalTrials.gov