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NCT03009019 · ClinicalTrials.gov registry record · Phase 3
Efficacy, Tolerability, and Safety of DFN-15
A Phase 3 study of Migraine Headache, sponsored by BioDelivery Sciences International.
- Completed
- Registry status
- Phase 3
- Development phase
- 631
- Enrollment target
- 20
- Study locations
NCT03009019: Completed Phase 3 study of Migraine Headache, sponsored by BioDelivery Sciences International.
NCT03009019 is a Phase 3 study of Migraine Headache that has completed, run by BioDelivery Sciences International. The registered enrollment target is 631 participants, above the 54-participant average among 6 other Migraine Headache trials with a reported enrollment target (1069% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03009019, a Phase 3 study of Migraine Headache, has completed, sponsored by BioDelivery Sciences International.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 631 participants
- Enrollment target
- 20
- Study locations
Study Summary
Efficacy, Tolerability, and Safety of DFN-15 in episodic migraine with or without aura, being conducted at multiple centers in the United States
Primary Outcome
The primary efficacy end point (for first treated DB1 attack only) were the percentage of subjects who were pain-free 2 hours postdose compared between DFN-15 and placebo (defined as a reduction from predose moderate \[Grade 2\] or severe \[Grade 3\] pain to none \[Grade 0\]
Conditions Studied
Interventions
- DRUG DFN-15 Active
- OTHER DFN-15 Placebo
Study Locations (20)
California
- Site 637 - Huntington Beach
- Site 615 - Oakland
- Site 646 - San Diego
- Site 619 - San Francisco
- Site 624 - San Marcos
Florida
- Site 603 - Miami
- Site 641 - Orange City
- Site 629 - Orlando
- Site 601 - West Palm Beach
Alabama
- Site 609 - Birmingham
- Site 640 - Mobile
Georgia
- Site 625 - Decatur
- Site 630 - Sandy Springs
Arizona
- Site 622 - Tucson
Arkansas
- Site 616 - Hot Springs
Colorado
- Site 631 - Littleton
Idaho
- Site 642 - Meridian
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 631 participants |
| Start Date | 2016-12 |
| Est. Completion | 2019-05 |
| Phase | Phase 3 |
What the finished NCT03009019 record still lists
NCT03009019 is an interventional study that assigns participants to a tested intervention. The registered 631 participants enrollment target is mid-sized for trials with a published cap, above the 54-participant average among 6 other Migraine Headache trials with a reported enrollment target (1069% higher).
The record links to 1 condition, with Migraine Headache appearing as the primary indexed condition, and to 2 interventions - of which DFN-15 Active is the first listed.
NCT03009019 names 20 study sites across 11 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT03009019 about?
NCT03009019 is a clinical study titled "Efficacy, Tolerability, and Safety of DFN-15". Efficacy, Tolerability, and Safety of DFN-15 in episodic migraine with or without aura, being conducted at multiple centers in the United States
What is the current status of trial NCT03009019?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 631 participants. The study started on 2016-12. Estimated completion is 2019-05.
What conditions does trial NCT03009019 study?
This clinical trial studies the following conditions: Migraine Headache.
What interventions are being tested in trial NCT03009019?
The interventions under investigation include: DFN-15 Active (DRUG), DFN-15 Placebo (OTHER).
Who is sponsoring clinical trial NCT03009019?
This trial is sponsored by BioDelivery Sciences International, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03009019 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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