NCT01908192

Adaptive Phase II Study to Evaluate the Safety & Efficacy of NaBen®

An Adaptive, Phase IIb/III, Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy OF NaBen® , A D-Amino Acid Oxidase Inhibitor, as an Add-on Treatment for Schizophrenia in Adolescents

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: SyneuRx International (Taiwan) Corp · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if NaBen® is a safe and effective add-on treatment for schizophrenia in adolescents.

Detailed description

This is a two-part, multi-center, prospective, randomized, placebo-controlled, parallel-group study, in which adolescent subjects with schizophrenia will be enrolled. Overall, eligible subjects will be randomized in a pre-defined 1:1 ratio to NaBen® or placebo. This study will be conducted in two parts: In Part 1 (Phase IIb) of the study, 76 subjects (\~ 60% of the total planned subjects) will be randomized in a 1:1 ratio (NaBen® or placebo), of which 38 subjects will be randomized to the NaBen® group and 38 subjects to the placebo group. An interim analysis (IA) will be conducted after the randomization of the 76th subject in Part 1 of the study. The data will be analyzed after all enrolled subjects in Part 1 of the study complete Visit 5 (week 6) or are withdrawn from the study, whichever occurs first. The data from IA will be reviewed by an independent Data Safety and Monitoring Committee (DSMC) that will be responsible for the review of the data from the Part 1 (Phase IIb) of the study for both safety and the effectiveness. In Part 2 (Phase III) of the study, a total of 50 subjects will be randomized, of which 25 subjects will be randomized to the NaBen® group and 25 subjects to the placebo group. The final subject numbers in the study will depend on the sample size re-estimation after Part 1 of the study.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	NaBen®	The Study Treatment is NaBen®, which will look, and will be packaged and maintained exactly the same way as the Control Treatment (Placebo).
DRUG	Placebo	The ingredients in the Control Treatment are exactly the same as in the Study Treatment, except without the primary active ingredient.

Timeline

• Start date: 2014-06-01
• Primary completion: 2023-10-26
• Completion: 2023-10-26
• First posted: 2013-07-25
• Last updated: 2024-05-09

Locations

23 sites across 2 countries: United States, Taiwan