Last updated on May 2018

Study to Evaluate Safety & Efficacy of NaBen as Add-on Treatment for Schizophrenia in Adults


Brief description of study

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.

Detailed Study Description

This is an adaptive, phase IIb/III, multi-center, prospective, randomized, placebo-controlled study, 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, and 8 week double-blind treatment part, and a 52 week Open-Label Extension part.

Screening part of the study:

The subjects will be evaluated for eligibility during the Screening part of the study.

Enrichment run-in part of the study:

Subjects who are determined to be eligible will enter the Run-in part of the study. A total of 348 Subjects will be randomized. The randomized subjects will receive 4 weeks of NaBen or Placebo accordingly. The subjects who have completed 4 weeks of randomized treatment in both groups (NaBen or Placebo) will be assessed and categorized intoresponders and non-responders, based on 20% or more reduction from baseline in their PANSS total scores as per the evaluations at Visit 2 and Visit 4.

Double-Blind treatment part of the study :

  • Subjects who have successfully completed the Enrichment Run-in part will enter the Double- Blind treatment part of the study per below: NaBen treated subjects: Subjects will continue receiving NaBen for another 8 weeks.
  • Placebo treated subjects:
  • Placebo Responders: Subjects will continue receiving Placebo for another 8 weeks.
  • Placebo Non-responders: Subjects will be re-randomized to receive NaBen or Placebo in a 1:1 ratio for another 8 weeks.

Open-Label Extension part of the study:

All subjects who have completed the Double-Blind part of the study will continue with the Open-Label Extension part of the study to receive NaBen for an additional 52 weeks, plus a 2 week follow-up.

Clinical Study Identifier: NCT02261519

Contact Investigators or Research Sites near you

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Felicia Yao

For additional information regarding investigative sites for this trial, contact SyneuRx International Corp.
Pasadena, CA United States
7.84miles
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Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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