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

September 10, 2021 updated by: SyneuRx International (Taiwan) Corp

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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 The data will be analyzed after all enrolled subjects in Part 1 of the study complete Visit 5 (week 6) or are withdrawn from the study, whichever occurs first.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.

Study Type

Interventional

Enrollment (Anticipated)

126

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • New Taipei City, Taiwan
        • Recruiting
        • Chang Gung Memorial Hospital (Linkou)
        • Contact:
          • Chiu Feng Lin (林), BA
          • Phone Number: 3815 +886-3-328-1200
        • Contact:
          • Hsin Yi Dai, BA
          • Phone Number: 8539 +886-3-328-1200
        • Principal Investigator:
          • Hsin Yi Liang, MD
        • Sub-Investigator:
          • Yu Hsu Huang, MD
        • Sub-Investigator:
          • Wei Chih Chin, MD
      • Taipei, Taiwan
        • Recruiting
        • Chang Gung Memorial Hospital (Taipei)
        • Contact:
          • Hsin Yi Dai （戴）, BA
          • Phone Number: 8539 +886-3-3281200
        • Contact:
          • Chiu Feng Lin
          • Phone Number: 3815 +886-3-328-1200
        • Principal Investigator:
          • Yu Hsu Huang, MD
        • Sub-Investigator:
          • Hsin Yi Liang, MD
      • Taipei, Taiwan
        • Recruiting
        • Veteran General Hospital Taipei
        • Contact:
          • Shi Hui Wang (王), BA
          • Phone Number: 305 ＋886-28757027
        • Principal Investigator:
          • Yin Chao Lee, MD
        • Sub-Investigator:
          • Kai Ling Huang, MD
        • Sub-Investigator:
          • Ju Wei Hsu, MD
        • Sub-Investigator:
          • Mu Hong Chen, MD
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36303
        • Recruiting
        • Harmonex Neuroscience Research
        • Contact:
        • Principal Investigator:
          • Nelson Handal, MD
    • California
      • Bellflower, California, United States, 90706
        • Recruiting
        • CITrials
        • Contact:
        • Principal Investigator:
          • Elizabeth Zarate-Rowell, MD
      • Long Beach, California, United States, 90807
        • Recruiting
        • Renew Behavioral Health, Inc.
        • Contact:
        • Principal Investigator:
          • Laja Ibraheem, MD
      • Riverside, California, United States, 92506
        • Recruiting
        • CITrials
        • Contact:
        • Principal Investigator:
          • Gerald Maguire, MD
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Recruiting
        • Institute of Living/Hartford Hospital
        • Contact:
        • Principal Investigator:
          • John Goethe, MD
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • Children's National Health System
        • Contact:
        • Principal Investigator:
          • Adelaide S Robb, MD
    • Florida
      • Miami, Florida, United States, 33122
        • Recruiting
        • Premier Clinical Research Institute
        • Contact:
        • Principal Investigator:
          • Emilio Mantero-Atienza, MD
      • Orange City, Florida, United States, 32763
        • Recruiting
        • Medical Research Group of Central Florida
        • Contact:
        • Principal Investigator:
          • Adly Thebaud, MD
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Recruiting
        • Atlanta Center for Medical Research
        • Principal Investigator:
          • Robert Riesenberg, MD
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • John Hopkins University - Hugo W Moser Research Institute at Kennedy Krieger Inc.
        • Contact:
        • Principal Investigator:
          • Robert L Findling, MD, MBA
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • University of Massachusetts Medical School - Psychiatry Department
        • Contact:
        • Principal Investigator:
          • Jean A Frazier, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Recruiting
        • Michigan Clinical Research Institute
        • Contact:
        • Principal Investigator:
          • RP Rajarethinam, MD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • Recruiting
        • University of Minnesota Medical Center - Department of Psychiatry
        • Contact:
        • Principal Investigator:
          • Sanjiv Kumra, MD
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Recruiting
        • Precise Research Centers
        • Principal Investigator:
          • Joseph Kwentus, MD
        • Contact:
    • New York
      • Rochester, New York, United States, 14618
        • Recruiting
        • Finger Lakes Clinical Research
        • Contact:
        • Principal Investigator:
          • Sarah Atkinson, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati - Dept. of Psychiatry and Behavioral Neuroscience
        • Principal Investigator:
          • Melissa Delbello, MD
        • Contact:
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Case Medical Center
        • Contact:
        • Principal Investigator:
          • Nora McNamara, MD
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Focus and Balance LLC
        • Contact:
        • Principal Investigator:
          • Ariel De Llanos, MD
    • Washington
      • Bothell, Washington, United States, 98011
        • Recruiting
        • Pacific Institute of Medical Sciences
        • Contact:
          • Syed J Mustafa, MD
          • Phone Number: 425-949-5779
          • Email: pi@pspc.org
        • Principal Investigator:
          • Syed J Mustafa, MD
      • Richland, Washington, United States, 99352
        • Recruiting
        • Zain Research, LLC
        • Contact:
        • Principal Investigator:
          • Cheta Nand, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
The control treatment is placebo.
Drug: Placebo
The ingredients in the Control Treatment are exactly the same as in the Study Treatment, except without the primary active ingredient.
Experimental: NaBen®
NaBen® is a white oral tablet (500 mg), which will be taken twice daily at a total dose of 1000 mg/day during this study.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change from baseline in Positive and Negative Syndrome Scale (PANSS) total score after 6 weeks of treatment
Time Frame: Positive and Negative Syndrome Scale will be assessed at Visit 1 (Screening), Visit 3, 4, 5, and 6.
Positive and Negative Syndrome Scale will be assessed at Visit 1 (Screening), Visit 3, 4, 5, and 6.

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent change from baseline in Positive and Negative Syndrome Scale (PANSS) total score from baseline after 6 weeks of treatment
Time Frame: Positive and Negative Syndrome Scale will be assessed at Visit 1 (Screening), Visit 3, 4, 5, and 6.
Positive and Negative Syndrome Scale will be assessed at Visit 1 (Screening), Visit 3, 4, 5, and 6.
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
Time Frame: Positive and Negative Syndrome Scale will be assessed at Visit 1 (Screening), Visit 3, 4, 5, and 6
Positive and Negative Syndrome Scale will be assessed at Visit 1 (Screening), Visit 3, 4, 5, and 6
Percent change in Positive and Negative Syndrome Scale (PANSS) sub-scales
Time Frame: Positive and Negative Syndrome Scale will be assessed at Visit 1 (Screening), Visit 3, 4, 5, and 6.
Positive and Negative Syndrome Scale will be assessed at Visit 1 (Screening), Visit 3, 4, 5, and 6.
Percent change in Scale for Assessment of Negative Symptoms (SANS) total scores
Time Frame: Scale for Assessment of Negative Symptoms will be assessed at Visit 1 (Screening), Visit 3,4,5, and 6
Scale for Assessment of Negative Symptoms will be assessed at Visit 1 (Screening), Visit 3,4,5, and 6
Percent change in Scale for Assessment of Negative Symptoms (SANS) sub-scale scores
Time Frame: Scale for Assessment of Negative Symptoms will be assessed at Visit 1 (Screening), Visit 3,4,5, and 6
Scale for Assessment of Negative Symptoms will be assessed at Visit 1 (Screening), Visit 3,4,5, and 6
Percent change from baseline in the PANSS total score after 6 weeks of treatment
Time Frame: Positive and Negative Syndrome Scale will be assessed at Visit 1 (Screening), Visit 3, 4, 5, and 6
Positive and Negative Syndrome Scale will be assessed at Visit 1 (Screening), Visit 3, 4, 5, and 6

Other Outcome Measures

Outcome Measure
Time Frame
Percent change in Children's Global Assessment Scale (CGAS)
Time Frame: Children's Global Assessment Scale will be assessed at Visit 1(Screening), Visit 3, 4, 5, and 6
Children's Global Assessment Scale will be assessed at Visit 1(Screening), Visit 3, 4, 5, and 6
Percent change in Clinical Global Impression-Severity (CGI-S)
Time Frame: Clinical Global Impression will be assessed at Visit 1 (Screening), Visit 3, 4, 5, and 6
Clinical Global Impression will be assessed at Visit 1 (Screening), Visit 3, 4, 5, and 6
Percent change in Children's Depression Rating Scale-Revised (CDRS-R)
Time Frame: Children's Depression Rating Scale will be assessed at Visit 1 (Screening), Visit 3, 4, 5, and 6
Children's Depression Rating Scale will be assessed at Visit 1 (Screening), Visit 3, 4, 5, and 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SyneuRx International (Taiwan) Corp

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

July 23, 2013

First Submitted That Met QC Criteria

July 23, 2013

First Posted (Estimate)

July 25, 2013

Study Record Updates

Last Update Posted (Actual)

September 13, 2021

Last Update Submitted That Met QC Criteria

September 10, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNR-01-NaBen

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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