At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 365 enrolled
Drug / intervention
ZP-Zolmitriptan +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating ZP-Zolmitriptan and Placebo for Acute Migraine. Completed, enrolled 365 participants across 36 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Migraine
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 2016
Enrollment StartJun 2016
Primary CompletionJan 2017
TodayJul 2026
First PostedApr 20, 2016
Enrollment StartJun 1, 2016
Primary CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 10.2 years ago
Interventions
ZP-Zolmitriptandrug
ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system
Placebodrug
Placebo patch(es) to match ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system (one or two patches)