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NCT03488563 · ClinicalTrials.gov registry record · Phase 2
Study to Determine Safety and Efficacy of B244 in Subjects With Episodic Migraine
A Phase 2 study of Migraine, sponsored by AOBiome.
- Completed
- Registry status
- Phase 2
- Development phase
- 313
- Enrollment target
- 20
- Study locations
NCT03488563: Completed Phase 2 study of Migraine, sponsored by AOBiome.
NCT03488563 is a Phase 2 study of Migraine that has completed, run by AOBiome. The registered enrollment target is 313 participants, below the 355-participant average among 102 other Migraine trials with a reported enrollment target (12% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03488563, a Phase 2 study of Migraine, has completed, sponsored by AOBiome.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 313 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Safety and tolerability endpoints will consist of all adverse events reporting during the study duration.
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 |
What the finished NCT03488563 record still lists
NCT03488563 is an interventional study that assigns participants to a tested intervention. The registered 313 participants enrollment target is mid-sized for trials with a published cap, below the 355-participant average among 102 other Migraine trials with a reported enrollment target (12% lower).
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.
NCT03488563 names 20 study sites across 13 states, led by Florida, California, Massachusetts.
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.
What interventions are being tested in trial NCT03488563?
The interventions under investigation include: Vehicle (BIOLOGICAL), B244 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03488563?
This trial is sponsored by AOBiome, which has 11 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Migraine
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03488563's enrollment target sits among peer trials
313 31st of 102 higher than 72 of 102 other Migraine trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Migraine trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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A Study to Investigate the Safety and Efficacy of MEDI0618 Compared to Placebo in Adult Participants With Episodic Migraine
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A Dose-finding Trial With Lu-AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments
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