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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 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.

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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.

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

FieldValue
Enrollment Target 313 participants
Start Date 2018-03-30
Est. Completion 2019-07-16
Phase Phase 2

Sponsor

AOBiome

11 total trials

What the Registry Record Tells You About NCT03488563

The ClinicalTrials.gov registry entry for NCT03488563 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 313 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 355-participant average among 102 other Migraine trials with a reported enrollment target (12% lower). The listed sponsor is AOBiome, which has 11 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.

Similar trials for Migraine

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.