At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 275 enrolled
Drug / intervention
100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally +1 moredrug
Likely dose
100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasallyfrom 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, Double-Dummy, Active-Controlled, Cross-Over Study Evaluating the Efficacy and Safety of 20 mg Sumatriptan Powder Delivered Intranasally With the Bi-directional Device Compared With 100 mg Sumatriptan Tablets in Adults With Acute Migraine With or Without Aura
In Brief
A Phase 3 clinical trial evaluating 100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally and OPTINOSE SUMATRIPTAN delivered nasally and placebo tablet for Migraine and Headaches. Completed, enrolled 275 participants across 13 sites.
Detailed Summary
This study is being conducted to determine if OPTINOSE SUMATRIPTAN delivered nasally (through the nose) using the OPTINOSE SUMATRIPTAN DEVICE can reduce the pain associated with migraine headaches in 30 minutes after use.
Study Details
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2012
First PostedAug 2012
Primary CompletionMar 2014
Study CompletionJun 2014
TodayJul 2026
First PostedAug 17, 2012
Enrollment StartAug 1, 2012
Primary CompletionMar 1, 2014
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 13.9 years ago
Interventions
100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasallydrug
OPTINOSE SUMATRIPTAN delivered nasally and placebo tabletdrug