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Study to Determine Safety and Efficacy of B244 in Subjects With Episodic Migraine

NCT03488563 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 313

Last updated 2022-10-04

Study results available
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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

Interventions

BIOLOGICAL

B244

B244 Suspension

BIOLOGICAL

Vehicle

Vehicle Suspension

Sponsors & Collaborators

  • Veristat, Inc.

    collaborator OTHER

  • AOBiome LLC

    lead INDUSTRY

Principal Investigators

  • Judith Ng-Cashin, MD · Chief Medical Officer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-30
Primary Completion
2019-06-17
Completion
2019-07-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03488563 on ClinicalTrials.gov