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COMPLETED Phase 3

Efficacy, Tolerability, and Safety of DFN-15

NCT03009019 · View on ClinicalTrials.gov ↗

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

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

FieldValue
Enrollment Target 631 participants
Start Date 2016-12
Est. Completion 2019-05
Phase Phase 3

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03009019

The ClinicalTrials.gov registry entry for NCT03009019 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 631 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioDelivery Sciences International, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03009019 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Florida, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03009019?

The interventions under investigation include: DFN-15 Active (DRUG), DFN-15 Placebo (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03009019?

This trial is sponsored by BioDelivery Sciences International, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial