NCT03488563

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

A Prospective, Randomized, Vehicle-Controlled, Double-Blind, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of B244 Delivered as an Intranasal Spray for Preventive Treatment in Subjects With Episodic Migraine

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 313 (actual)
• Sponsor: AOBiome LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a Prospective, Randomized, Vehicle-controlled, Double-blind, Multi-center, 3-arm study assessing the safety, tolerability, and efficacy of B244 delivered as an intranasal spray for preventive treatment in subjects with episodic migraine. At Screening and Baseline, all subjects must experiences 4-14 migraine days per month and 3-14 migraine attacks per month and no more than 14 headache days per month in the 3 months prior to screening. The total duration of the study will be approximately 16 weeks. Participants will report for a Screening visit and if all inclusion criteria are met, subjects will go through a one month baseline period prior to randomization. Subjects will come in for visits at Day 28 (Week 4), Day 56 (Week8), Day 84 (Week12), and Day 112 (Week 16). Efficacy will be assessed by change in migraine attacks, days, and hours. Blood and urine samples will be collected for standard safety laboratory testing and the effect of the drug on inflammatory biomarkers. Safety will be monitored throughout the study. Investigators plan to enroll 303 total subjects. Subjects will be randomized 1:1:1 so that an equal number of subjects will be treated in each arm of the study.

Conditions

• Migraine

Interventions

Type	Name	Description
BIOLOGICAL	B244	B244 Suspension
BIOLOGICAL	Vehicle	Vehicle Suspension

Timeline

• Start date: 2018-03-30
• Primary completion: 2019-06-17
• Completion: 2019-07-16
• First posted: 2018-04-05
• Last updated: 2022-10-04
• Results posted: 2022-10-04

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated drug study