At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 107 enrolled
Drug / intervention
Sumatriptan 10 mg Nasal Spray +1 moredrug
Likely dose
Sumatriptan 10 mg nasal spray, 100 μL, once per migraine episodeAI-extracted
Key inclusion· 5
- ✓History of episodic migraine with 2-8 attacks per month averaged over past 12 months
- ✓No more than 14 headache days per month
- ✓At least 48 hours of headache-free time between migraine headaches
- ✓Migraine with or without aura; if with aura, aura duration ≤60 minutes
Key exclusion· 11
- ✕Minors excluded regardless of age eligibility
- ✕Opioid use ≥10 days in prior 90 days
- ✕Combination medications with opioid/barbiturate ≥10 days in prior 90 days
- ✕NSAIDs or simple medications >14 days per month in prior 90 days
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of DFN-02 in Episodic Migraine With or Without Aura
In Brief
A Phase 2 clinical trial evaluating Sumatriptan 10 mg Nasal Spray and Sumatriptan Placebo Nasal Spray for Migraine Headaches. Completed, enrolled 107 participants across 9 sites.
Detailed Summary
A safety and efficacy study of DFN-02 (Sumatriptan Nasal Spray 10 mg), being conducted at multiple centers in the United States.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine Headaches
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartJul 2016
First PostedAug 2016
Primary CompletionFeb 2017
TodayJul 2026
First PostedAug 5, 2016
Enrollment StartJul 11, 2016
Primary CompletionFeb 10, 2017
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 9.9 years ago
Interventions
Sumatriptan 10 mg Nasal Spraydrug
100 μL nasal spray once
Sumatriptan Placebo Nasal Sprayother
100 μL nasal spray once