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Study to Evaluate Safety & Efficacy of NaBen® as Add-on Treatment for Schizophrenia in Adults

Primary Purpose

Schizophrenia

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NaBen®
Placebo
Sponsored by
SyneuRx International (Taiwan) Corp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male/female subjects between 18 and 45 years of age
  2. If female and not infertile (defined below), the subject must agree for the duration of the study to use one of the following forms of contraception 1) systemic hormonal treatment 2) an Intrauterine device (IUD) which was implanted at least 2 months prior to screening or 3) "double-barrier" contraception (condom, diaphragm and spermicide are each considered a barrier). Females are considered to be infertile if they are either a) surgically sterile or b) have had spontaneous amenorrhea for at least the last 2 years and at least 2 years after the onset of amenorrhea while not receiving hormone replacement therapy and had a Follicle-Stimulating Hormone (FSH) level greater than 40 mIU/mL and an estradiol level less than 30 pg/mL
  3. Subject is capable of providing informed consent and is willing to sign the ICF prior to study Screening and agrees to comply with the study protocol requirements
  4. Physician confirmed DSM-V diagnosis of schizophrenia for the past 2 years based on subject's history and confirmed by psychiatric evaluation and MINI International Neuropsychiatric Interview For Schizophrenia and Psychotic Disorders, version 7.0 (MINI, Version 7.0)
  5. The subject is outpatient with no hospitalization for worsening of schizophrenia within 3 months of the screening.If the subject is hospitalized during the study for worsening of schizophrenia symptoms the subject will be withdrawn from the study
  6. The subject's schizophrenia condition is clinically stable with residual symptoms. Residual symptoms will be defined as a total score of ≤110 and ≥ 60 of PANSS per Visit 1 evaluations
  7. An unchanged antipsychotic medication regimen for at least eight (8) weeks prior to screening into the study and expected to remain unchanged during the study (longer for depot or long-acting antipsychotics: ten (10) months for Aripiprazole and Paliperidone; six (6) months for Olanzapine pamoate monohydrate; and at least 6 times duration of the reported half life or minimum four (4) months for other depot or long-acting antipsychotics)
  8. In good general physical health and without clinically significant abnormalities in physical exam, neurological exam and laboratory assessments (urine/blood routine, biochemical tests and ECG) which would exclude the subject from the study in the opinion of the Investigator. For ALT and AST, clinically significant is defined as above twice the upper limit of normal.
  9. BMI between 17 and 35 inclusive
  10. Subject has a negative routine urine illicit drug screening test (including heroin, amphetamines (including MDMA/ecstasy), cocaine, cannabis or PCP)
  11. The subject has a caregiver or some other identified responsible person (e.g., family member, social worker, caseworker or nurse) as determined by the Investigator and per the local regulations. The identified caregiver should be considered reliable by the Investigator and per the local regulations in providing support to the subject to help ensure compliance with study treatment, study visits and protocol procedures who preferably is also able to provide input helpful for completing study rating scales
  12. The subject must not be a danger to self or others per the Investigator's judgment

Exclusion Criteria:

  1. Meets the DSM-IV or V criteria at screening for intellectual disability, dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, primary substance-induced psychotic disorder, dementia, or any other comorbid mental disorders that in the opinion of the Investigator may interfere with study conduct and results interpretation
  2. Subjects whose illness was resistant to antipsychotics according to prior trials of two different antipsychotics of adequate dose
  3. Subjects who have been previously treated with or are receiving clozapine
  4. Initiation or dose change of lithium, antidepressant or other mood stabilizers within 16 weeks prior to screening
  5. Initiation or dose change of benzodiazepines or sleep medications due to worsening of schizophrenia symptoms or medication side effects, or any other psychotropic medications within 4 weeks prior to screening
  6. The subject has previously received NaBen®
  7. History of epilepsy, major head trauma, or any neurological illness other than Tourette's syndrome which might impair the subject's cognition or psychiatric functioning per the investigator's judgment
  8. History of allergic reaction to sodium benzoate
  9. Serious medical illnesses such as end-stage renal disease, liver failure or heart failure that, in the opinion of the Investigator, may interfere with the conduct of the study
  10. Any significant gastrointestinal disorders that, in the opinion of the investigator, markedly alter the absorption, metabolism or elimination of sodium benzoate
  11. Any movement disorders with a total score higher than 6 on SAS scale, or more than 2 on any items of the AIMS scale
  12. Current substance abuse, or history of meeting criteria for moderate or severe substance abuse (including alcohol, but excluding nicotine and caffeine) in the past six (6) months prior to screening
  13. Female subjects who are pregnant (as confirmed by urine pregnancy test performed at Screening Visit) or are breast feeding
  14. History of cancer not in remission for the last 3 years except for basal cell carcinoma and squamous cell carcinoma
  15. Participation in a clinical trial within 3 months prior to screening or more than two clinical trials within 12 months
  16. Electroconvulsive Therapy within 6 months prior to screening
  17. The subject started a new non-medication treatment for schizophrenia or other psychiatric condition within the last 3 months prior to screening
  18. The subject's anti-EPS medications dose or regimen has changed within 2 weeks prior to screening

Sites / Locations

  • For additional information regarding investigative sites for this trial, contact SyneuRx International Corp.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NaBen®

Placebo

Arm Description

NaBen® is a oral tablet (500 mg), which will be taken twice daily at a total dose of 1000 mg/day during this study.

The control treatment is placebo.

Outcomes

Primary Outcome Measures

Positive and Negative Syndrome Scale (PANSS)
Mean change from baseline in PANSS total score

Secondary Outcome Measures

Positive and Negative Syndrome Scale (PANSS)
Percent change from baseline in PANSS total score
Positive and Negative Syndrome Scale (PANSS)
Percentage of subjects with 20% or more reduction from baseline in PANSS total score
PANSS sub-scale scores and Marder PANSS factor scores
Percent change in PANSS sub-scale scores and Marder PANSS factor scores
Personal and Social Performance (PSP) scale
Percent change of Personal and Social Performance (PSP) scale

Full Information

First Posted
September 25, 2014
Last Updated
September 10, 2021
Sponsor
SyneuRx International (Taiwan) Corp
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1. Study Identification

Unique Protocol Identification Number
NCT02261519
Brief Title
Study to Evaluate Safety & Efficacy of NaBen® as Add-on Treatment for Schizophrenia in Adults
Official Title
An Adaptive, Phase IIb/III, Multi-center, Prospective, Randomized, Double-Blind Placebo-controlled Study of the Safety and Efficacy of NaBen® (DAAO Inhibitor), as an Add-on Treatment for Schizophrenia in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2017 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SyneuRx International (Taiwan) Corp

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The proposed Phase IIb/III study is designed to evaluate the safety and efficacy of NaBen® in improving the symptoms of schizophrenia in adults. NaBen® is granted Breakthrough Therapy Designation by US FDA as add-on treatment for schizophrenia. The trial is designed as a multi-center, prospective, randomized, placebo-controlled, in which adult subjects with schizophrenia will be enrolled. The study will include four parts: a 2 week Screening part, a 4 week run-in part, an 8 week double-blind treatment part, and a 52 week Open-Label Extension part.
Detailed Description
This is an adaptive, phase IIb/III, multi-center, prospective, randomized, placebo-controlled study, in which adult subjects with schizophrenia will be enrolled. The study will include four parts: a 2 week Screening part, a 4 week run-in part, and 8 week double-blind treatment part, and a 52 week Open-Label Extension part. Screening part of the study: The subjects will be evaluated for eligibility during the Screening part of the study. Enrichment run-in part of the study: Subjects who are determined to be eligible will enter the Run-in part of the study. A total of 348 Subjects will be randomized. The randomized subjects will receive 4 weeks of NaBen® or Placebo accordingly. The subjects who have completed 4 weeks of randomized treatment in both groups (NaBen® or Placebo) will be assessed and categorized intoresponders and non-responders, based on 20% or more reduction from baseline in their PANSS total scores as per the evaluations at Visit 2 and Visit 4. Double-Blind treatment part of the study : Subjects who have successfully completed the Enrichment Run-in part will enter the Double- Blind treatment part of the study per below: NaBen® treated subjects: Subjects will continue receiving NaBen® for another 8 weeks. Placebo treated subjects: Placebo Responders: Subjects will continue receiving Placebo for another 8 weeks. Placebo Non-responders: Subjects will be re-randomized to receive NaBen® or Placebo in a 1:1 ratio for another 8 weeks. Open-Label Extension part of the study: All subjects who have completed the Double-Blind part of the study will continue with the Open-Label Extension part of the study to receive NaBen® for an additional 52 weeks, plus a 2 week follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
348 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NaBen®
Arm Type
Experimental
Arm Description
NaBen® is a oral tablet (500 mg), which will be taken twice daily at a total dose of 1000 mg/day during this study.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The control treatment is placebo.
Intervention Type
Drug
Intervention Name(s)
NaBen®
Intervention Description
500 mg twice daily (1000 mg total)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
0 mg twice daily (0 mg total)
Primary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale (PANSS)
Description
Mean change from baseline in PANSS total score
Time Frame
8 weeks after randomized treatment
Secondary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale (PANSS)
Description
Percent change from baseline in PANSS total score
Time Frame
8 weeks after treatment
Title
Positive and Negative Syndrome Scale (PANSS)
Description
Percentage of subjects with 20% or more reduction from baseline in PANSS total score
Time Frame
8 weeks after treatment
Title
PANSS sub-scale scores and Marder PANSS factor scores
Description
Percent change in PANSS sub-scale scores and Marder PANSS factor scores
Time Frame
8 weeks after treatment
Title
Personal and Social Performance (PSP) scale
Description
Percent change of Personal and Social Performance (PSP) scale
Time Frame
8 weeks after treatment
Other Pre-specified Outcome Measures:
Title
Positive and Negative Syndrome Scale (PANSS)
Description
Maintenance of treatment effect for PANSS total score
Time Frame
64 weeks
Title
Personal and Social Performance (PSP) scale
Description
Maintenance of treatment effect in PSP scale
Time Frame
64 weeks
Title
Schizophrenia Quality of Life Scale (SQLS)
Description
Percent change and maintenance of treatment effect in Schizophrenia Quality of Life Scale (SQLS)
Time Frame
64 weeks
Title
Clinical Global Impression-Severity (CGI-S) and -improvement (CGI-I)
Description
Percent change and maintenance of treatment effect in Clinical Global Impression-Severity (CGI-S) and -improvement (CGI-I) for both overall and negative symptoms
Time Frame
64 weeks
Title
Hamilton Depression Rating Scale (HDRS)
Description
Percent change in Hamilton Depression Rating Scale (HDRS)
Time Frame
64 weeks
Title
Serum analysis
Description
Serum pharmacokinetic evaluations, DNA evaluations and neurotransmitter markers evaluations
Time Frame
12 weeks
Title
Treatment-Emergent Adverse Events (TEAE)
Description
Incidence of TEAE and incidence of withdrawals from the study due to TEAEs
Time Frame
64 weeks
Title
Simpson-Angus extrapyramidal side effects (SAS) scale
Description
Percent change in Simpson-Angus extrapyramidal side effects (SAS) scale
Time Frame
64 weeks
Title
Abnormal Involuntary Movement Scale (AIMS)
Description
Percent change in Abnormal Involuntary Movement Scale (AIMS)
Time Frame
64 weeks
Title
Barnes Akathisia Rating Scale (BARS)
Description
Percent change in Barnes Akathisia Rating Scale (BARS)
Time Frame
64 weeks
Title
Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
Assessment of suicidality per the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame
64 weeks
Title
Laboratory measurements (e.g., Hematology, Biochemistry, Urine analysis)
Description
Changes and shifts in laboratory measurements (e.g., Hematology, Biochemistry, Urine analysis) over time
Time Frame
64 weeks
Title
Vital signs (e.g., Body temperature, Heart rate, Respiration rate, Blood pressure)
Description
Changes in vital signs (e.g., Body temperature, Heart rate, Respiration rate, Blood pressure) over time
Time Frame
64 weeks
Title
Weight (e.g., BMI in kg/m2)
Description
Changes in weight (e.g., BMI in kg/m2)over time
Time Frame
64 weeks
Title
Electrocardiogram (ECG) parameters
Description
Changes in Electrocardiogram (ECG) parameters over time
Time Frame
64 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male/female subjects between 18 and 45 years of age If female and not infertile (defined below), the subject must agree for the duration of the study to use one of the following forms of contraception 1) systemic hormonal treatment 2) an Intrauterine device (IUD) which was implanted at least 2 months prior to screening or 3) "double-barrier" contraception (condom, diaphragm and spermicide are each considered a barrier). Females are considered to be infertile if they are either a) surgically sterile or b) have had spontaneous amenorrhea for at least the last 2 years and at least 2 years after the onset of amenorrhea while not receiving hormone replacement therapy and had a Follicle-Stimulating Hormone (FSH) level greater than 40 mIU/mL and an estradiol level less than 30 pg/mL Subject is capable of providing informed consent and is willing to sign the ICF prior to study Screening and agrees to comply with the study protocol requirements Physician confirmed DSM-V diagnosis of schizophrenia for the past 2 years based on subject's history and confirmed by psychiatric evaluation and MINI International Neuropsychiatric Interview For Schizophrenia and Psychotic Disorders, version 7.0 (MINI, Version 7.0) The subject is outpatient with no hospitalization for worsening of schizophrenia within 3 months of the screening.If the subject is hospitalized during the study for worsening of schizophrenia symptoms the subject will be withdrawn from the study The subject's schizophrenia condition is clinically stable with residual symptoms. Residual symptoms will be defined as a total score of ≤110 and ≥ 60 of PANSS per Visit 1 evaluations An unchanged antipsychotic medication regimen for at least eight (8) weeks prior to screening into the study and expected to remain unchanged during the study (longer for depot or long-acting antipsychotics: ten (10) months for Aripiprazole and Paliperidone; six (6) months for Olanzapine pamoate monohydrate; 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 without clinically significant abnormalities in physical exam, neurological exam and laboratory assessments (urine/blood routine, biochemical tests and ECG) which would exclude the subject from the study in the opinion of the Investigator. For ALT and AST, clinically significant is defined as above twice the upper limit of normal. BMI between 17 and 35 inclusive Subject has a negative routine urine illicit drug screening test (including heroin, amphetamines (including MDMA/ecstasy), cocaine, cannabis or PCP) The subject has a caregiver or some other identified responsible person (e.g., family member, social worker, caseworker or nurse) as determined by the Investigator and per the local regulations. The identified caregiver should be considered reliable by the Investigator and per the local regulations in providing support to the subject to help ensure compliance with study treatment, study visits and protocol procedures who preferably is also able to provide input helpful for completing study rating scales The subject must not be a danger to self or others per the Investigator's judgment Exclusion Criteria: Meets the DSM-IV or V criteria at screening for intellectual disability, dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, primary substance-induced psychotic disorder, dementia, or any other comorbid mental disorders that in the opinion of the Investigator may interfere with study conduct and results interpretation Subjects whose illness was resistant to antipsychotics according to prior trials of two different antipsychotics of adequate dose Subjects who have been previously treated with or are receiving clozapine Initiation or dose change of lithium, antidepressant or other mood stabilizers within 16 weeks prior to screening Initiation or dose change of benzodiazepines or sleep medications due to worsening of schizophrenia symptoms or medication side effects, or any other psychotropic medications within 4 weeks prior to screening The subject has previously received NaBen® History of epilepsy, major head trauma, or any neurological illness other than Tourette's syndrome which might impair the subject's cognition or psychiatric functioning per the investigator's judgment History of allergic reaction to sodium benzoate Serious medical illnesses such as end-stage renal disease, liver failure or heart failure that, in the opinion of the Investigator, may interfere with the conduct of the study Any significant gastrointestinal disorders that, in the opinion of the investigator, markedly alter the absorption, metabolism or elimination of sodium benzoate Any movement disorders with a total score higher than 6 on SAS scale, or more than 2 on any items of the AIMS scale Current substance abuse, or history of meeting criteria for moderate or severe substance abuse (including alcohol, but excluding nicotine and caffeine) in the past six (6) months prior to screening Female subjects who are pregnant (as confirmed by urine pregnancy test performed at Screening Visit) or are breast feeding History of cancer not in remission for the last 3 years except for basal cell carcinoma and squamous cell carcinoma Participation in a clinical trial within 3 months prior to screening or more than two clinical trials within 12 months Electroconvulsive Therapy within 6 months prior to screening The subject started a new non-medication treatment for schizophrenia or other psychiatric condition within the last 3 months prior to screening The subject's anti-EPS medications dose or regimen has changed within 2 weeks prior to screening
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yashar Salek, MD
Phone
1-301-956-2527
Email
yashars@amarexcro.com
First Name & Middle Initial & Last Name or Official Title & Degree
Felicia Yao
Phone
886-2-77422699
Ext
136
Email
felicia.yao@syneurx.com
Facility Information:
Facility Name
For additional information regarding investigative sites for this trial, contact SyneuRx International Corp.
City
Pasadena
State/Province
California
ZIP/Postal Code
91101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felicia Yao
Phone
027-742-2699
Ext
136
Email
felicia.yao@syneurx.com

12. IPD Sharing Statement

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Study to Evaluate Safety & Efficacy of NaBen® as Add-on Treatment for Schizophrenia in Adults

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