Date

2022-11-25

Protocol

Protocol changed

Item Changed

Intervention(s) planned

Previous Version

Study Sites • Colombo North Teaching Hospital This is a 6-week, open-label, randomized,rater blinded multi-center study designed to evaluate the safety, tolerability and preliminary efficacy of fixed doses of evenamide of 7.5 mg bid, 15 mg bid and 30 mg bid as add-on treatment in patients with treatment-resistant schizophrenia on a stable therapeutic dose of an antipsychotic. A minimum of 150 patients will be allocated equally to each of the three treatment groups (50 patients per group). Doses will be initiated in a stepwise fashion. Initially, only the 7.5 mg bid and 15 mg bid doses will be evaluated with a 1:1 randomization scheme. After 50 patients (25 patients in each treatment group) have been treated at these doses, key safety data from these patients will be reviewed by an independent safety monitoring board (ISMB). If this review of the data indicates there are no safety issues, the 30 mg bid dose group will be initiated, and an additional 100 patients will be randomly assigned (1:1:2) to the 7.5, 15 and 30 mg bid treatment groups, with 25, 25 and 50 patients, respectively, enrolled in each group. However, if a decision is made not to include the 30 mg bid dose group in the study, an additional 100 patients will be randomly assigned (1:1) to the 7.5 and 15 mg twice daily treatment groups for a total of 150 patients enrolled, with approximately 75 in each group. Intervention1: NW3509: Fixed oral doses of 7.5, 15 mg BID orally for 6 weeks therapy of NW-3509 (Evenamide)

Next Version

This is a 6-week, open-label, randomized, rater-blinded, multi-center study designed to evaluate the safety, tolerability and preliminary efficacy of fixed doses of evenamide of 7.5 mg bid, 15 mg bid and 30 mg bid as addon treatment in patients with treatment-resistant schizophrenia on a stable therapeutic dose of an antipsychotic. Approximately 180 patients will be enrolled to ensure that minimally 50 patients are randomized to each of the three treatment groups allocated equally to each of the three treatment groups (approximately 50 patients per group). Doses will be initiated in a stepwise fashion. Initially, only the 7.5 mg bid and 15 mg bid doses were evaluated with a 1:1 randomization scheme. After 50 patients (approximately 25 patients in each treatment group) were treated at these doses, key safety data from these patients were reviewed by an Independent Safety Monitoring Board (ISMB). Since this review of the data indicated there are no safety issues, the 30 mg bid dose group was initiated, and additional patients randomly assigned (1:1:2) to the 7.5, 15 and 30 mg bid treatment groups. Subsequently, with implementation of this amendment to the Study 014 protocol, the 7.5 mg bid dose group will be discontinued, and patients will be randomized 1:3 to doses of 15 mg bid and 30 mg bid, respectively. No further patients will be enrolled in the 7.5 mg bid group.