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

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519237-34-00
Acronym
SNR-05
Enrollment
50
Registered
2025-01-28
Start date
2019-11-26
Completion date
Unknown
Last updated
2025-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment for Refractory Schizophrenia in Adults

Brief summary

Mean change from baseline in Positive and Negative Syndrome Scale (PANSS) total score after 8 weeks of randomized treatment

Detailed description

Percent change from baseline in PANSS total score after 8 weeks of treatment, Percentage of subjects with 20% or more reduction from baseline in PANSS total score after 8 weeks of treatment, Percent change in PANSS sub-scales and Marder PANSS factor scores, Percent change in Personal and Social Performance (PSP) scale, Percent change in Schizophrenia Quality of Life Scale (SQLS), Percent change in Clinical Global Impression-Severity (CGI-S) and -improvement (CGI-I), Percent change in Hamilton Depression Rating Scale (HDRS), Serum pharmacokinetic evaluations

Interventions

DRUGPlacebo for NaBen
DRUGNaBen F.C.T.II

Sponsors

Syneurx International (Taiwan) Corp.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Mean change from baseline in Positive and Negative Syndrome Scale (PANSS) total score after 8 weeks of randomized treatment

Secondary

MeasureTime frame
Percent change from baseline in PANSS total score after 8 weeks of treatment, Percentage of subjects with 20% or more reduction from baseline in PANSS total score after 8 weeks of treatment, Percent change in PANSS sub-scales and Marder PANSS factor scores, Percent change in Personal and Social Performance (PSP) scale, Percent change in Schizophrenia Quality of Life Scale (SQLS), Percent change in Clinical Global Impression-Severity (CGI-S) and -improvement (CGI-I), Percent change in Hamilton Depression Rating Scale (HDRS), Serum pharmacokinetic evaluations

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026