Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 55Years
All Genders
NCT03094429

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

Led by SyneuRx International (Taiwan) Corp · Updated on 2021-09-13

287

Participants Needed

1

Research Sites

509 weeks

Total Duration

On this page

Sponsors

S

SyneuRx International (Taiwan) Corp

Lead Sponsor

A

Amarex Clinical Research

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female subjects between 18 and 55 years old inclusive
  • Able to provide informed consent or have a legal representative to consent
  • If female and fertile, agree to use effective contraception during the study
  • Diagnosed with schizophrenia for at least 2 years confirmed by psychiatric evaluation
  • Meet criteria for refractory schizophrenia with prior non-response to 2 antipsychotics and persistent symptoms
  • Receiving clozapine for at least 6 months at 200-900 mg/day with stable dose for 3 months
  • Outpatient with consistent symptoms and no hospitalization for worsening in past 3 months
  • PANSS total score of at least 70 at screening and baseline
  • No clinically significant abnormalities in exams or labs, including liver enzymes
  • Body mass index between 17 and 38 inclusive
  • Negative urine test for illicit drugs
  • Have a reliable caregiver or responsible person to assist with study compliance
  • Not a danger to self or others per investigator judgment
Not Eligible

You will not qualify if you...

  • Diagnosed with intellectual disability, bipolar disorder, major depression, or other mental disorders interfering with study
  • Recent changes in lithium, antidepressants, mood stabilizers, benzodiazepines, or other psychotropic drugs
  • Previous treatment with NaBen4
  • History of epilepsy, major head trauma, or neurological illness affecting cognition
  • Allergic reaction to sodium benzoate
  • Serious medical illnesses like end-stage renal disease, liver failure, or heart failure
  • Significant gastrointestinal disorders affecting drug absorption
  • Movement disorders exceeding certain severity thresholds
  • Current or recent moderate to severe substance abuse (excluding nicotine and caffeine)
  • Pregnant or breastfeeding females
  • History of cancer not in remission for 3 years except certain skin cancers
  • Participation in recent clinical trials or multiple trials within a year
  • Electroconvulsive therapy within past 6 months
  • Recent new non-medication treatments for schizophrenia
  • Recent changes in anti-extrapyramidal symptom medication
  • Recent significant symptom improvement exceeding 20% reduction on PANSS score

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

For additional information regarding investigative sites for this trial, contact SyneuRx International Corp.

Pasadena, California, United States, 91101

Actively Recruiting

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Research Team

Y

Yashar Salek, MD

CONTACT

F

Felicia Yao

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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