Axsome Therapeutics Begins CLARITY Phase 3 Trial
Axsome Therapeutics announced that the first patient has been dosed in the CLARITY Phase 3 trial of solriamfetol in the treatment of major depressive disorder with excessive daytime sleepiness symptoms. CLARITY is a Phase 3, double-blind, placebo-controlled, multicenter randomized withdrawal trial in patients with MDD with EDS symptoms consisting of an open-label solriamfetol treatment period and a randomized, double-blind treatment period. Patients achieving a treatment response during the open-label period will be randomized in a 1:1 ratio to continue solriamfetol or to switch to placebo. The primary endpoint will be the time from randomization to relapse of depressive symptoms.
