SNR01
Research type
Research Study
Full title
An Adaptive, Phase IIb/III, Double-Blind, Randomised, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of Naben (Sodium Benzoate), A Damino Acid Oxidase Inhibitor, as an Add-On Treatment for Schizophrenia in Adolescents
IRAS ID
282278
Contact name
Pushparaja Sekaran
Contact email
Sponsor organisation
SyneuRX International (Taiwan) Corp
Eudract number
2017-001168-39
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NCT01908192, US NCT Number
Duration of Study in the UK
2 years, 0 months, 2 days
Research summary
This is a two-part, multi-center, randomized, placebo-controlled, study, in which a total of 126 adolescent participants with Schizophrenia will be randomly assigned to the study drug NaBen® or Placebo (63 in the NaBen® group and 63 in the placebo group). This study will look at how safe and how well the investigational drug NaBen®, in addition to standard conventional therapy, works in improving childrens psychosis symptoms
The study will be conducted in two parts:
Part one (phase IIb): 76 patients will be randomised to either NaBen® or Placebo.
Part two (phase III): 50 patients will be randomised to NaBen® or Placebo.The primary aim of the part two phase of this study is to evaluate the effectiveness of NaBen® (sodium benzoate) (1000 mg/day), as compared to Placebo (0 mg/day), in improving the negative and positive symptoms associated with schizophrenia in adolescents.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
20/SC/0239
Date of REC Opinion
21 Sep 2020
REC opinion
Further Information Favourable Opinion