Study to Evaluate Safety & Efficacy of NaBen® as Add-on Treatment for Schizophrenia in Adults
Status:
Recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
Summary
The proposed Phase IIb/III study is designed to evaluate the safety and efficacy of NaBen® in
improving the symptoms of schizophrenia in adults. NaBen® is granted Breakthrough Therapy
Designation by US FDA as add-on treatment for schizophrenia. The trial is designed as a
multi-center, prospective, randomized, placebo-controlled, in which adult subjects with
schizophrenia will be enrolled. The study will include four parts: a 2 week Screening part, a
4 week run-in part, an 8 week double-blind treatment part, and a 52 week Open-Label Extension
part.