Adaptive Phase II Study to Evaluate the Safety & Efficacy of NaBen®

Schizophrenia Clinical Trial

Official title:

An Adaptive, Phase IIb/III, Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy OF NaBen® , A D-Amino Acid Oxidase Inhibitor, as an Add-on Treatment for Schizophrenia in Adolescents

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01908192
• Other study ID #: SNR-01-NaBen
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: June 2014
• Est. completion date: October 26, 2023

Study information

• Verified date: May 2024
• Source: SyneuRx International (Taiwan) Corp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if NaBen® is a safe and effective add-on treatment for schizophrenia in adolescents.

Description:

This is a two-part, multi-center, prospective, randomized, placebo-controlled, parallel-group study, in which adolescent subjects with schizophrenia will be enrolled. Overall, eligible subjects will be randomized in a pre-defined 1:1 ratio to NaBen® or placebo.

This study will be conducted in two parts:

In Part 1 (Phase IIb) of the study, 76 subjects (~ 60% of the total planned subjects) will be randomized in a 1:1 ratio (NaBen® or placebo), of which 38 subjects will be randomized to the NaBen® group and 38 subjects to the placebo group. An interim analysis (IA) will be conducted after the randomization of the 76th subject in Part 1 of the study. The data will be analyzed after all enrolled subjects in Part 1 of the study complete Visit 5 (week 6) or are withdrawn from the study, whichever occurs first. The data from IA will be reviewed by an independent Data Safety and Monitoring Committee (DSMC) that will be responsible for the review of the data from the Part 1 (Phase IIb) of the study for both safety and the effectiveness.

In Part 2 (Phase III) of the study, a total of 50 subjects will be randomized, of which 25 subjects will be randomized to the NaBen® group and 25 subjects to the placebo group. The final subject numbers in the study will depend on the sample size re-estimation after Part 1 of the study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: October 26, 2023
• Est. primary completion date: October 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

• Male or female subjects who are between 12 and 17 years of age inclusive

• Physician confirmed DSM-IV or -V diagnosis of schizophrenia based on MINI International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorders Studies for Children and Adolescents, version 6.0 (MINI-KID, Version 6.0)

• Are clinically stable with residual symptoms, defined as a total score of = 60 of PANSS and a score of = 40 for SANS

• An unchanged antipsychotic medication regimen for at least eight (8) weeks prior to randomization into the study and expected to remain unchanged during the study (longer for depot or long-acting antipsychotics: ten (10) months for Aripiprazole (Maintena®) and Paliperidone (Xeplion®); six (6) months for Olanzapine pamoate monohydrate (Zypadhera®); and at least 6 times duration of the reported half life or minimum four (4) months for other depot or long-acting antipsychotics)

• In good general physical health and all physical exam, neurological exam and laboratory assessments (urine/blood routine, biochemical tests and ECG) are clinically unremarkable per the investigator

• Subject has a negative urine illicit drug screening test

• Subject understands and is willing to sign the Informed Assent Form (IAF) prior to study entry and agrees to be available for all the study visits

• The subject's guardian understands and is willing to sign the Informed Consent Form (ICF) prior to study entry and agrees to be available for all the study visits

• Must not be a danger to self or others and must have family support available to be maintained as outpatients

Exclusion Criteria:

• Meets the DSM-IV or -V criteria at screening for mental retardation, dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, or primary substance induced psychotic disorder. Other comorbid disorders; e.g., attention-deficit hyperactivity disorder (ADHD), are allowed as long as schizophrenia is the primary diagnosis and the comorbid disorder(s) do not require medication.

• Subjects whose illness was resistant to antipsychotics according to prior trials of two different antipsychotics of adequate dose

• History of epilepsy, head trauma, or neurological illness other than Tourette's syndrome

• History of allergic reaction to sodium benzoate

• Serious medical illnesses such as acute or chronic renal disease, liver failure or heart disease that, in the opinion of the investigator, may interfere with the conduct of the study.

• Current substance abuse or positive urine illicit drug screening or history of substance dependence (including alcohol, but excluding nicotine and caffeine) in the past three (3) months.

• Use of depot antipsychotics in the past six (6) months

• Inability to follow protocol

• Body Mass Index (BMI) > 35

• Female subjects who are pregnant (as confirmed by urine pregnancy test performed at screening Visit) or are nursing, or who do not agree to abstinence or birth control during the study

• Cancer within the last three (3) years except for basal cell carcinoma and squamous cell carcinoma

• Previous participation in an intervention trial within 30 days of randomization

• Subjects whose PANSS score has decreased more than 10 percent during the Screening Phase

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• NaBen®
The Study Treatment is NaBen®, which will look, and will be packaged and maintained exactly the same way as the Control Treatment (Placebo).
• Placebo
The ingredients in the Control Treatment are exactly the same as in the Study Treatment, except without the primary active ingredient.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital (Linkou)	New Taipei City
Taiwan	Chang Gung Memorial Hospital (Taipei)	Taipei
Taiwan	Veteran General Hospital Taipei	Taipei
United States	Michigan Clinical Research Institute	Ann Arbor	Michigan
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	John Hopkins University - Hugo W Moser Research Institute at Kennedy Krieger Inc.	Baltimore	Maryland
United States	CiTrials	Bellflower	California
United States	Pacific Institute of Medical Sciences	Bothell	Washington
United States	University of Cincinnati - Dept. of Psychiatry and Behavioral Neuroscience	Cincinnati	Ohio
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	Harmonex Neuroscience Research	Dothan	Alabama
United States	Precise Research Centers	Flowood	Mississippi
United States	Institute of Living/Hartford Hospital	Hartford	Connecticut
United States	Renew Behavioral Health, Inc.	Long Beach	California
United States	Premier Clinical Research Institute	Miami	Florida
United States	University of Minnesota Medical Center - Department of Psychiatry	Minneapolis	Minnesota
United States	Medical Research Group of Central Florida	Orange City	Florida
United States	Zain Research, LLC	Richland	Washington
United States	CiTrials	Riverside	California
United States	Finger Lakes Clinical Research	Rochester	New York
United States	Focus and Balance LLC	San Antonio	Texas
United States	Children's National Health System	Washington	District of Columbia
United States	University of Massachusetts Medical School - Psychiatry Department	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
SyneuRx International (Taiwan) Corp

Countries where clinical trial is conducted

United States,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percent change in Children's Global Assessment Scale (CGAS)		Children's Global Assessment Scale will be assessed at Visit 1(Screening), Visit 3, 4, 5, and 6
Other	Percent change in Clinical Global Impression-Severity (CGI-S)		Clinical Global Impression will be assessed at Visit 1 (Screening), Visit 3, 4, 5, and 6
Other	Percent change in Children's Depression Rating Scale-Revised (CDRS-R)		Children's Depression Rating Scale will be assessed at Visit 1 (Screening), Visit 3, 4, 5, and 6
Primary	Mean change from baseline in Positive and Negative Syndrome Scale (PANSS) total score after 6 weeks of treatment		Positive and Negative Syndrome Scale will be assessed at Visit 1 (Screening), Visit 3, 4, 5, and 6.
Secondary	Percent change from baseline in Positive and Negative Syndrome Scale (PANSS) total score from baseline after 6 weeks of treatment		Positive and Negative Syndrome Scale will be assessed at Visit 1 (Screening), Visit 3, 4, 5, and 6.
Secondary	Percentage of subjects with 20% or more reduction in Positive and Negative Syndrome Scale (PANSS) total score from baseline after six (6) weeks of treatment		Positive and Negative Syndrome Scale will be assessed at Visit 1 (Screening), Visit 3, 4, 5, and 6
Secondary	Percent change in Positive and Negative Syndrome Scale (PANSS) sub-scales		Positive and Negative Syndrome Scale will be assessed at Visit 1 (Screening), Visit 3, 4, 5, and 6.
Secondary	Percent change in Scale for Assessment of Negative Symptoms (SANS) total scores		Scale for Assessment of Negative Symptoms will be assessed at Visit 1 (Screening), Visit 3,4,5, and 6
Secondary	Percent change in Scale for Assessment of Negative Symptoms (SANS) sub-scale scores		Scale for Assessment of Negative Symptoms will be assessed at Visit 1 (Screening), Visit 3,4,5, and 6
Secondary	Percent change from baseline in the PANSS total score after 6 weeks of treatment		Positive and Negative Syndrome Scale will be assessed at Visit 1 (Screening), Visit 3, 4, 5, and 6

External Links

•   Sponsor
•   The clinical trial management organization
•   Trial Background