Clinical Trial: Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of BMS-986089 in Ambulatory Boys With Duchenne Muscular Dystrophy
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: A Randomized, Double Blind, Placebo-Controlled, Study to Assess the Efficacy, Safety, and Tolerability of BMS-986089 in Ambulatory Boys With Duchenne Muscular Dystrophy
Brief Summary: This is a multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy, safety and tolerability of two different weekly doses of BMS-986089 in ambulatory boys with Duchenne Muscular Dystrophy (DMD).
Detailed Summary:
Sponsor: Bristol-Myers Squibb
Current Primary Outcome:
- Change from baseline in the 4 stair climb velocity in BMS-986089 treated participants. [ Time Frame: 48 Week ]Number of seconds to complete 4 stair climb.
- Change from baseline in the 4 stair climb velocity in placebo treated participants. [ Time Frame: 48 Week ]Number of seconds to complete 4 stair climb.
Original Primary Outcome:
- Change from baseline in the 4 stair climb velocity in BMS-986089 treated participants. [ Time Frame: 48 Week ]
- Change from baseline in the 4 stair climb velocity in placebo treated participants. [ Time Frame: 48 Week ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Bristol-Myers Squibb
Dates:
Date Received: January 27, 2017
Date Started: May 31, 2017
Date Completion: July 30, 2020
Last Updated: May 2, 2017
Last Verified: May 2017