Positive results have been announced from phase III study evaluating the efficacy and safety of lumateperone for the prevention of relapse in adult patients with schizophrenia. Study 304 was a phase III, multicenter, multinational, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy of lumateperone (42 mg daily) in preventing relapse of symptoms in adult patients with schizophrenia. The study had two phases: an 18-week open-label phase and a 26-week double-blind phase. During the open-label phase, patients were treated with lumateperone and those who met stabilization criteria were eligible to move on to the double-blind phase. In this phase, patients were randomly assigned to continue on lumateperone (42 mg, N=114) or switch to a placebo (N=114). The primary endpoint of the study was the time to the first symptom relapse, and the key secondary endpoint was the time to all-cause discontinuation during the double-blind phase. The study aimed to determine whether continuing lumateperone would help prevent relapse and reduce discontinuation compared to placebo.

Results for the primary endpoint of time to relapse was significantly longer in patients receiving lumateperone compared to those on placebo (p=0.0002). There were 18 relapses (16.4%) in the lumateperone group, compared to 44 relapses (38.6%) in the placebo group, representing a 63% reduction in the risk of relapse with lumateperone (hazard ratio = 0.37, 95% CI: 0.22–0.65). Additionally, lumateperone met the key secondary endpoint of time to all-cause discontinuation during the double-blind phase, with a statistically significant result (p=0.0007), indicating that patients on lumateperone were less likely to discontinue treatment compared to those on placebo. In this study, lumateperone was generally safe and well tolerated. In the double-blind phase, the most commonly reported adverse event that was observed at a rate greater than or equal to 5% and twice the rate of placebo was headache.

Reference:

Intra-Cellular Therapies, Inc. Press Release