Conditions: Acute Migraine
Keywords: migraine migraine headache acute migraine acute migraine headache
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 365
Healthy volunteers: no

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.

Arms:
arm 1: ZP-Zolmitriptan 1 mg patch single administration arm 2: ZP-Zolmitriptan 1.9 mg patch single administration arm 3: ZP-Zolmitriptan 3.8 mg (1.9 mg x 2 patches) single administration arm 4: Placebo (either single or double patch) single administration

Interventions: intervention 1: ZP-Zolmitriptan intervention 2: Placebo
Intervention descriptions: intervention 1: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system intervention 2: Placebo patch(es) to match ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system (one or two patches)

Protocol document: