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Study to Determine Safety and Efficacy of B244 in Subjects With Episodic Migraine
NCT03488563 · View on ClinicalTrials.gov ↗
Study Summary
This is a prospective, randomized, vehicle-controlled, double-blind, multi-center study assessing the safety, tolerability, and efficacy of B244 delivered as an intranasal spray for preventive treatment in subjects with episodic migraine.
Conditions Studied
Interventions
- BIOLOGICAL Vehicle
- BIOLOGICAL B244
Study Locations (20)
Florida
- Clinical Neuroscience Solution, Inc — Jacksonville
- Precision Clinical Research — Lauderdale Lakes
- Clinical Neuroscience Solution, Inc — Orlando
- Palm Beach Research — West Palm Beach
California
- Collaborative Neuroscience Network, LLC — Long Beach
- CI Trials — Riverside
- Neurological Research Institute — Santa Monica
Massachusetts
- BTC of New Bedford — New Bedford
- MedVadis Research — Watertown
Texas
- FutureSearch Trials of Neurology and Sleep Lab, L.P. — Austin
- FutureSearch Trials of Dallas, L.P. — Dallas
Arkansas
- Baptist Health Center for Clinical Research — Little Rock
Connecticut
- New England Institute for Neurology and Headache (NEINH)/Medical Practice — Stamford
Georgia
- Neurostudies Clinical Research — Decatur
Nevada
- Altea Research Institute — Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 313 participants |
| Start Date | 2018-03-30 |
| Est. Completion | 2019-07-16 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03488563
The ClinicalTrials.gov registry entry for NCT03488563 describes a study currently listed as completed. It is categorized as Phase 2, 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 313 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AOBiome, 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 appearing as the primary indexed condition, and to 2 interventions — of which Vehicle 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: NCT03488563 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Florida, California, Massachusetts. 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 NCT03488563 about?
NCT03488563 is a clinical study titled "Study to Determine Safety and Efficacy of B244 in Subjects With Episodic Migraine". This is a prospective, randomized, vehicle-controlled, double-blind, multi-center study assessing the safety, tolerability, and efficacy of B244 delivered as an intranasal spray for preventive treatment in subjects with episodic migraine.
What is the current status of trial NCT03488563?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 313 participants. The study started on 2018-03-30. Estimated completion is 2019-07-16.
What conditions does trial NCT03488563 study?
This clinical trial studies the following conditions: Migraine. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03488563?
The interventions under investigation include: Vehicle (BIOLOGICAL), B244 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03488563?
This trial is sponsored by AOBiome, 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 NCT03488563 being conducted?
This trial has 20 study locations across Arkansas, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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