Add-on NaBen treatment of Refractory Schizophrenia in Adults

• Research type

  Research Study

• Full title

  An adaptive Phase II/III, Double-Blind, Randomized, Placebo-controlled, Two-Part, Dose-Finding, Multi-center Study of the Safety and Efficacy of NaBen® (sodium benzoate), a D-Amino Acid Oxidase Inhibitor, as an Add-on with Clozapine, for Residual Symptoms of Refractory Schizophrenia in Adults

• IRAS ID

  263280

• Contact name

  Sukhwinder Singh Shergill

• Contact email

  SUKHI.SHERGILL@KCL.AC.UK

• Sponsor organisation

  SyneuRx International (Taiwan) Corp

• Eudract number

  2017-001170-42

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  Adult schizophrenia presents both negative and positive symptoms and cognitive deficits. Current effective treatments-conventional anti-psychotics and atypical anti-psychotics, target selective neurotransmitters in varying degrees of effectiveness. This also may cause extra-pyramidal side effects to be suffered by the patient. There is also a considerable number of patients resistant to or partially responsive to the available treatments. Most schizophrenic patients suffer a life-long illness with deteriorating function.
  There is an urgent need to find a treatment with a better safety and efficacy profile to improve both symptoms and cognitive deficit.
  This study will be conducted in two parts:
  In Part 1 (i.e. dose finding portion) of the study One hundred seventy one (171) subjects will be randomized in a 1:1:1 ratio (NaBen® 2000 mg/day: NaBen® 1000 mg/day: Placebo).

  After all the patients have participated in Part 1 for at least 8 weeks, an interim analysis will be performed by an independent committee. The interim analysis will determine (1) whether the study should continue (2) whether adjustment of the number of patients in Part 2 is required and (3) the optimal dose.

  For Part 2 of the study a total of 116 subjects will be randomized in a 1:1 ratio, of which 58 subjects will be randomized to the NaBen® optimal dose group and 58 subjects to the Placebo group. The procedures and assessments for subjects in Part 1 and Part 2 of this study will be identical with the exception of the randomization schema.

  The study will require each participant to fulfil 7 study visits overall- which will involve provision of a Blood sample for testing and to complete symptom and quality of life questionnaires.
  Recruitment of eligible participants will take place at carefully selected hospital sites that have both the clinical expertise and experience to ensure optimal care for the study participants.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  19/EM/0164

• Date of REC Opinion

  17 Jun 2019

• REC opinion

  Further Information Favourable Opinion