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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    126
  • sponsor
    SyneuRx International (Taiwan) Corp
Updated on 12 April 2020
Investigator
Yashar Salek, MD
Primary Contact
Children's National Health System (5.3 mi away) Contact
+22 other location
psychosis
antipsychotics
olanzapine
aripiprazole
medication regimen
paliperidone

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 The data will be analyzed after all enrolled subjects in Part 1 of the study complete Visit 5 (week 6) or are withdrawn from the study, whichever occurs first.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

Details
Treatment Placebo, NaBen®
Clinical Study IdentifierNCT01908192
SponsorSyneuRx International (Taiwan) Corp
Last Modified on12 April 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 12 yrs and 17 yrs?
Gender: Male or Female
Do you have any of these conditions: Schizophrenia or Schizophrenia and Schizoaffective Disorders or Schizophrenia and Schizoaffective Disorders (Pediatric)?
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
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