An Adaptive Phase II/III, Double-Blind, Randomized, Placebo-controlled, Two-Part, Dose-Finding, Multi-center Study of the Safety and Efficacy of NaBen®,a D-Amino Acid Oxidase Inhibitor, as an Add-on Therapy With Clozapine, for Residual Symptoms of Refractory Schizophrenia in Adults
Phase of Trial: Phase II/III
Latest Information Update: 19 May 2018
At a glance
- Drugs Sodium benzoate (Primary) ; Clozapine
- Indications Schizophrenia
- Focus Therapeutic Use
- Sponsors SyneuRx International (Taiwan) corp
- 31 Aug 2018 Biomarkers information updated
- 22 May 2017 According to a SyneuRx International media release, this study has been granted by the US FDA with both Orphan Drug Designation (ODD) and Breakthrough Therapy Designation (BTD). The first five patients have been randomized in this trial.
- 06 Apr 2017 Status changed from not yet recruiting to recruiting.