At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 223 enrolled
Drug / intervention
Sumatriptan +1 moredrug
Likely dose
Sumatriptan 20mgfrom 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 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of a Single 20 mg Dose of Sumatriptan Powder Delivered Intranasally With the Bi-directional Device in Adults With Acute Migraine With or Without Aura
In Brief
A Phase 3 clinical trial evaluating Sumatriptan and Placebo for Migraine Headache. Completed, enrolled 223 participants across 15 sites.
Detailed Summary
The study is being conducted to determine if OPTINOSE SUMATRIPTAN delivered nasally (through the nose) using the OPTINOSE SUMATRIPTAN Device can reduce the pain and symptoms associated with migraine headaches.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine Headache
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2011
First PostedOct 2011
Primary CompletionJun 2012
TodayJul 2026
First PostedOct 31, 2011
Enrollment StartJan 1, 2011
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 14.7 years ago
Interventions
Sumatriptandrug
Sumatriptan 20mg
Placebodrug
Matching placebo