At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 342 enrolled
Drug / intervention
M207 Microneedle Systemdrug
Likely dose
M207 Microneedle System 3.8 mgfrom 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.
A Long-Term, Open-Label Study to Evaluate the Safety of M207 (Zolmitriptan Intracutaneous Microneedle System) in the Acute Treatment of Migraine
In Brief
A Phase 3 clinical trial evaluating M207 Microneedle System for Migraine. Completed, enrolled 342 participants across 31 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedSep 2017
Enrollment StartNov 2017
Primary CompletionMay 2019
TodayJul 2026
First PostedSep 13, 2017
Enrollment StartNov 7, 2017
Primary CompletionMay 17, 2019
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 8.8 years ago
Interventions
M207 Microneedle Systemdrug
M207 Microneedle System 3.8 mg