CureDuchenne is pleased to share the following update to the Duchenne muscular dystrophy community from Lilly regarding the ongoing Phase 3 trial of tadalafil in boys with Duchenne.
Eli Lilly and Company is pleased to announce the completion of enrollment of the Phase 3 trial of tadalafil for patients with Duchenne muscular dystrophy (DMD).
The study, entitled A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Tadalafil for Duchenne Muscular Dystrophy (ClinicalTrials.gov #NCT01865084), is a 48-week clinical trial designed to determine the efficacy and safety of once-daily tadalafil treatment in ambulatory boys with DMD. The primary endpoint is the change in walking distance as measured by the six-minute walk test. Enrollment in the trial has ended with 331 patients randomized to placebo or one of 2 doses of tadalafil at 63 study sites globally. Top-line results from the trial are expected in the first half of 2016.
We would like to sincerely thank the many boys and their families who gave of their time to be screened for the trial, and for the continuing commitment of those patients who currently are participating in the trial. We also greatly appreciate the hard work and dedication of the site investigators and staff that made completion of enrollment possible.