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

NCT01908192 | Terminated Phase 2 DMC

• 1 other identifier: SNR-01-NaBen
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 23

Brief Summary

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

Conditions

Schizophrenia

Keywords

Sodium Benzoate; Schizophrenia; Adolescent; Antipsychotic; Anti-psychotic; NMDA; NaBen; pediatric

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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.

• 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

• 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.

• 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

• 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

Other Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

NaBen®

EXPERIMENTAL

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®

Placebo

PLACEBO COMPARATOR

The control treatment is placebo.

Drug: Placebo

Interventions

NaBen® DRUG

The Study Treatment is NaBen®, which will look, and will be packaged and maintained exactly the same way as the Control Treatment (Placebo).

NaBen®

Placebo DRUG

The ingredients in the Control Treatment are exactly the same as in the Study Treatment, except without the primary active ingredient.

Placebo

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SyneuRx International (Taiwan) Corp: lead

Study Sites (23)

Harmonex Neuroscience Research

Dothan, Alabama, 36303, United States

Location

CiTrials

Bellflower, California, 90706, United States

Location

Renew Behavioral Health, Inc.

Long Beach, California, 90807, United States

Location

CiTrials

Riverside, California, 92506, United States

Location

Institute of Living/Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

Children's National Health System

Washington D.C., District of Columbia, 20010, United States

Location

Premier Clinical Research Institute

Miami, Florida, 33122, United States

Location

Medical Research Group of Central Florida

Orange City, Florida, 32763, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

John Hopkins University - Hugo W Moser Research Institute at Kennedy Krieger Inc.

Baltimore, Maryland, 21287, United States

Location

University of Massachusetts Medical School - Psychiatry Department

Worcester, Massachusetts, 01655, United States

Location

Michigan Clinical Research Institute

Ann Arbor, Michigan, 48105, United States

Location

University of Minnesota Medical Center - Department of Psychiatry

Minneapolis, Minnesota, 55454, United States

Location

Precise Research Centers

Flowood, Mississippi, 39232, United States

Location

Finger Lakes Clinical Research

Rochester, New York, 14618, United States

Location

University of Cincinnati - Dept. of Psychiatry and Behavioral Neuroscience

Cincinnati, Ohio, 45219, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Focus and Balance LLC

San Antonio, Texas, 78229, United States

Location

Pacific Institute of Medical Sciences

Bothell, Washington, 98011, United States

Location

Zain Research, LLC

Richland, Washington, 99352, United States

Location

Chang Gung Memorial Hospital (Linkou)

New Taipei City, Taiwan

Location

Chang Gung Memorial Hospital (Taipei)

Taipei, Taiwan

Location

Veteran General Hospital Taipei

Taipei, Taiwan

Location

Related Links

• The clinical trial management organization
• Sponsor
• Trial Background

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Robert Findling, MD

  Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2013
• First Posted: July 25, 2013
• Study Start: June 1, 2014
• Primary Completion: October 26, 2023
• Study Completion: October 26, 2023
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

TW (3); US (20)