NCT03282227

A Study to Evaluate the Long-Term Safety of M207 in the Acute Treatment of Migraine

A Long-Term, Open-Label Study to Evaluate the Safety of M207 (Zolmitriptan Intracutaneous Microneedle System) in the Acute Treatment of Migraine

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 342 (actual)
• Sponsor: Zosano Pharma Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, twelve-month safety study. There is a screening period followed by a run-in period to record migraine activity. Qualified subjects will receive study medication for up to twelve months for the treatment of multiple migraine attacks. Using the electronic diary (eDiary) to confirm they are experiencing a qualified migraine, subjects will self-administer the patches and respond to questions in the eDiary post treatment administration.

Detailed description

This is an open-label, twelve-month safety study. There is a screening period followed by a run-in period (14 to 21 days) to determine eligibility for treatment with study medication based on daily eDiary data collection. Qualified subjects will receive study medication on Day 1 for up to twelve months for the treatment of migraine headaches. Migraines will be treated with a single dose, consisting of two patches, but subjects can treat multiple migraine attacks throughout the 12 months. Using the eDiary to confirm they are experiencing a qualified migraine, subjects will self-administer the patches and continue to respond to questions in the eDiary for 48 hours post treatment administration.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	M207 Microneedle System	M207 Microneedle System 3.8 mg

Timeline

• Start date: 2017-11-07
• Primary completion: 2019-05-17
• Completion: 2019-05-17
• First posted: 2017-09-13
• Last updated: 2020-08-19
• Results posted: 2020-08-19

Locations

31 sites across 1 country: United States

Regulatory

• FDA-regulated drug study