NaBen Add-On Therapy for Schizophrenia
Trial Summary
What is the purpose of this trial?
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.
Do I have to stop taking my current medications for the trial?
The trial requires participants to continue taking clozapine without changing the dose during the study. Other medications like lithium, antidepressants, mood stabilizers, benzodiazepines, or sleep medications should not have been started or had their doses changed recently. The protocol does not specify stopping other medications, but changes to certain medications close to the trial start may affect eligibility.
What data supports the idea that NaBen Add-On Therapy for Schizophrenia is an effective drug?
The available research shows that drugs, in general, have greater effectiveness than placebo in reducing negative symptoms in schizophrenia, although the effect size is small. This suggests that NaBen Add-On Therapy, as a drug, may also be effective in treating schizophrenia, but the data does not specifically highlight its effectiveness compared to other treatments.12345
What safety data is available for NaBen Add-On Therapy for Schizophrenia?
The provided research does not contain specific safety data for NaBen Add-On Therapy, Sodium Benzoate, or NaBen®. The studies focus on other antipsychotic drugs and placebo responses in schizophrenia trials, but do not mention NaBen or Sodium Benzoate. Therefore, no relevant safety data for NaBen is available in the given research.36789
Is the placebo a promising treatment for schizophrenia?
Eligibility Criteria
Adults aged 18-55 with refractory schizophrenia, who have not responded to at least two antipsychotic drugs and are on a stable dose of clozapine. Participants must be capable of consent or have a representative, agree to use contraception if applicable, and not have significant medical conditions or substance abuse issues.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part 1
Participants receive NaBen® (1000 or 2000 mg/day) or Placebo for dose-finding over 8 weeks
Interim Analysis
Data Safety and Monitoring Committee reviews data for safety and efficacy trends to determine optimal dose for Part 2
Treatment Part 2
Participants receive NaBen® at the optimal dose or Placebo for hypothesis testing over 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- NaBen®
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
SyneuRx International (Taiwan) Corp
Lead Sponsor
Amarex Clinical Research
Collaborator