An Adaptive Phase II/III, Two-Part, Double-Blind, Randomized, Placebo-controlled, Dose-Finding, Multi-center Study of the Safety and Efficacy of NaBen®, as an Add-on Therapy With Clozapine, for Residual Symptoms of Refractory Schizophrenia in Adults

Conditions

• Refractory Schizophrenia

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Not accepted

Interventions

• NaBen® — DRUG
  2000 mg/day or 1000 mg/day, twice daily
• Placebo — OTHER
  0 mg total, twice daily

Study Details

This is an adaptive, Phase II/III study in 2 parts (i.e. Part 1 (dose ranging) and Part 2 (Hypothesis testing)). NaBen® is granted Breakthrough Therapy Designation by US FDA as treatment for refractory schizophrenia. Part 1 Objectives: There are two primary objectives for Part 1 of this study: 1. To evaluate, in terms of dose-response, the effectiveness of NaBen® (1000 and 2000 mg/day) compared to Placebo (0 mg/day), when combined with clozapine, in improving the residual symptoms associated with refractory schizophrenia in adults, and; to determine the optimal dose to be used in Part 2 of this study. 2. Sample size re-assessment to evaluate the final sample size needed to proceed with Part 2 of the study The secondary objective of the Part 1 of this study is to evaluate the safety and tolerability of NaBen® (1000 and 2000 mg/day) compared to Placebo (0 mg/day), in combination with clozapine. Part 2 Objectives: The primary objective of the Part 2 of this study is to evaluate the effectiveness of NaBen® (at the optimal dose determined in the Part 1 of this study) compared to Placebo (0 mg/day), when combined with clozapine, in improving the residual symptoms associated with refractory schizophrenia in adults. The secondary objective of the Part 2 of this study is to evaluate the safety and tolerability of NaBen® (at the optimal dose determined in the Part 1 of this study) compared to Placebo (0 mg/day), in combination with clozapine.

Key Dates

Start date

Mar 29, 2017

Status verified

Sep 2021

Primary completion

Sep 30, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

287 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: NaBen® - 2000 mg/day
  Two NaBen® ( 500 mg) will be taken twice daily at a total dose of 2000 mg/day during this study.
• Active Comparator: NaBen® - 1000 mg/day
  One NaBen® (500 mg) and one placebo will be taken twice daily at a total dose of 1000 mg/day during this study.
• Placebo Comparator: Placebo - 0 mg/day
  The control treatment is placebo.

Primary Outcome Measure

Mean change from baseline in Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: 8 weeks after randomized treatment ]

Central Contacts

• Yashar Salek, MD
  1-301-956-2527
  [email protected]
• Felicia Yao
  886-2-77422699
  [email protected]

Locations (1)

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