Date

2020-12-03

Protocol

Protocol changed

Item Changed

Intervention(s) planned

Previous Version

•Study setting: Colombo North Teaching Hospital This is a 46-week, open-label, multi-center, extension to study NW-3509/014/II/2019 designed to evaluate the long-term safety, tolerability and preliminary efficacy of evenamide as add-on treatment in patients with treatment resistant schizophrenia on a stable therapeutic dose of an antipsychotic. In Study 014, 50 patients are to be randomized equally (1:1) to the 7.5 mg bid and 15 mg bid doses (approximately 25 in each group), and 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 randomization will continue, with a total of approximately 50 patients being enrolled in each of the three treatment groups. If the 30 mg bid group is not added, the 150 patients will be randomly assigned (1:1) to the 7.5 and 15 mg bid treatment groups (approximately 75 in each group). Intervention NW3509 Fixed oral doses of 30 mg BID orally for 46 weeks therapy of NW-3509 (Evenamide)

Next Version

• New study sites added. (District Hospital Kandana, District General Hospital Gampaha)