Last updated on May 2018

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


Brief description of study

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

Detailed Study 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 The data will be analyzed after all enrolled subjects in Part 1 of the study complete Visit 5 (week 6) or are withdrawn from the study, whichever occurs first.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.

Clinical Study Identifier: NCT01908192

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Medical Research Group of Central Florida

Orange City, FL United States
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