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NCT03094429 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Refractory Schizophrenia, sponsored by SyneuRx International (Taiwan).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 287
- Enrollment target
- 1
- Study location
NCT03094429: Recruiting Phase 2 study of Refractory Schizophrenia, sponsored by SyneuRx International (Taiwan).
NCT03094429 is a Phase 2 study of Refractory Schizophrenia that is actively recruiting participants, run by SyneuRx International (Taiwan). The registered enrollment target is 287 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (116% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03094429, a Phase 2 study of Refractory Schizophrenia, is actively recruiting participants, sponsored by SyneuRx International (Taiwan).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 287 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Mean change from baseline in Positive and Negative Syndrome Scale (PANSS) total score
Conditions Studied
Interventions
- OTHER Placebo
- DRUG NaBen®
Study Locations (1)
California
- For additional information regarding investigative sites for this trial, contact SyneuRx International Corp. - Pasadena
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 287 participants |
| Start Date | 2017-03-29 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What NCT03094429 shows while recruiting
NCT03094429 is an interventional study that assigns participants to a tested intervention. The registered 287 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (116% higher).
The record links to 1 condition, with Refractory Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03094429 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03094429 about?
NCT03094429 is a clinical study titled "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". 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. ...
What is the current status of trial NCT03094429?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 287 participants. The study started on 2017-03-29. Estimated completion is 2026-12-31.
What conditions does trial NCT03094429 study?
This clinical trial studies the following conditions: Refractory Schizophrenia.
What interventions are being tested in trial NCT03094429?
The interventions under investigation include: Placebo (OTHER), NaBen® (DRUG).
Who is sponsoring clinical trial NCT03094429?
This trial is sponsored by SyneuRx International (Taiwan), which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03094429 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03094429's enrollment target sits among peer trials
287 191st of 2000 higher than 1,810 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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