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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 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. The trial reports 1 study location across 1 state.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03094429
The ClinicalTrials.gov registry entry for NCT03094429 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 287 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SyneuRx International (Taiwan), which has 3 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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