Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2026-03-20 @ 11:33 AM
Study NCT ID:
NCT01908192
Status:
TERMINATED
Last Update Posted:
2024-05-09
First Post:
2013-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adaptive Phase II Study to Evaluate the Safety & Efficacy of NaBen®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2013-07-23', 'studyFirstSubmitQcDate': '2013-07-23', 'lastUpdatePostDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Percent change in Children's Global Assessment Scale (CGAS)", 'timeFrame': "Children's Global Assessment Scale will be assessed at Visit 1(Screening), Visit 3, 4, 5, and 6"}, {'measure': 'Percent change in Clinical Global Impression-Severity (CGI-S)', 'timeFrame': 'Clinical Global Impression will be assessed at Visit 1 (Screening), Visit 3, 4, 5, and 6'}, {'measure': "Percent change in Children's Depression Rating Scale-Revised (CDRS-R)", 'timeFrame': "Children's Depression Rating Scale will be assessed at Visit 1 (Screening), Visit 3, 4, 5, and 6"}], 'primaryOutcomes': [{'measure': 'Mean change from baseline in Positive and Negative Syndrome Scale (PANSS) total score after 6 weeks of treatment', 'timeFrame': 'Positive and Negative Syndrome Scale will be assessed at Visit 1 (Screening), Visit 3, 4, 5, and 6.'}], 'secondaryOutcomes': [{'measure': 'Percent change from baseline in Positive and Negative Syndrome Scale (PANSS) total score from baseline after 6 weeks of treatment', 'timeFrame': 'Positive and Negative Syndrome Scale will be assessed at Visit 1 (Screening), Visit 3, 4, 5, and 6.'}, {'measure': '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', 'timeFrame': 'Positive and Negative Syndrome Scale will be assessed at Visit 1 (Screening), Visit 3, 4, 5, and 6'}, {'measure': 'Percent change in Positive and Negative Syndrome Scale (PANSS) sub-scales', 'timeFrame': 'Positive and Negative Syndrome Scale will be assessed at Visit 1 (Screening), Visit 3, 4, 5, and 6.'}, {'measure': 'Percent change in Scale for Assessment of Negative Symptoms (SANS) total scores', 'timeFrame': 'Scale for Assessment of Negative Symptoms will be assessed at Visit 1 (Screening), Visit 3,4,5, and 6'}, {'measure': 'Percent change in Scale for Assessment of Negative Symptoms (SANS) sub-scale scores', 'timeFrame': 'Scale for Assessment of Negative Symptoms will be assessed at Visit 1 (Screening), Visit 3,4,5, and 6'}, {'measure': 'Percent change from baseline in the PANSS total score after 6 weeks of treatment', 'timeFrame': 'Positive and Negative Syndrome Scale will be assessed at Visit 1 (Screening), Visit 3, 4, 5, and 6'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sodium Benzoate', 'Schizophrenia', 'Adolescent', 'Antipsychotic', 'Anti-psychotic', 'NMDA', 'NaBen', 'pediatric'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amarexcro.com', 'label': 'The clinical trial management organization'}, {'url': 'http://www.syneurx.com', 'label': 'Sponsor'}, {'url': 'http://syneurx.net', 'label': 'Trial Background'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if NaBen® is a safe and effective add-on treatment for schizophrenia in adolescents.', 'detailedDescription': '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.\n\nThis study will be conducted in two parts:\n\nIn 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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female subjects who are between 12 and 17 years of age inclusive\n* 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)\n* Are clinically stable with residual symptoms, defined as a total score of ≥ 60 of PANSS and a score of ≥ 40 for SANS\n* 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)\n* 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\n* Subject has a negative urine illicit drug screening test\n* 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\n* 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\n* Must not be a danger to self or others and must have family support available to be maintained as outpatients\n\nExclusion Criteria:\n\n* 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.\n* Subjects whose illness was resistant to antipsychotics according to prior trials of two different antipsychotics of adequate dose\n* History of epilepsy, head trauma, or neurological illness other than Tourette's syndrome\n* History of allergic reaction to sodium benzoate\n* 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.\n* 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.\n* Use of depot antipsychotics in the past six (6) months\n* Inability to follow protocol\n* Body Mass Index (BMI) \\> 35\n* 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\n* Cancer within the last three (3) years except for basal cell carcinoma and squamous cell carcinoma\n* Previous participation in an intervention trial within 30 days of randomization\n* Subjects whose PANSS score has decreased more than 10 percent during the Screening Phase"}, 'identificationModule': {'nctId': 'NCT01908192', 'briefTitle': 'Adaptive Phase II Study to Evaluate the Safety & Efficacy of NaBen®', 'organization': {'class': 'INDUSTRY', 'fullName': 'SyneuRx International (Taiwan) Corp'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'SNR-01-NaBen'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NaBen®', 'description': '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.', 'interventionNames': ['Drug: NaBen®']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The control treatment is placebo.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'NaBen®', 'type': 'DRUG', 'description': 'The Study Treatment is NaBen®, which will look, and will be packaged and maintained exactly the same way as the Control Treatment (Placebo).', 'armGroupLabels': ['NaBen®']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'The ingredients in the Control Treatment are exactly the same as in the Study Treatment, except without the primary active ingredient.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36303', 'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'facility': 'Harmonex Neuroscience Research', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'zip': '90706', 'city': 'Bellflower', 'state': 'California', 'country': 'United States', 'facility': 'CiTrials', 'geoPoint': {'lat': 33.88168, 'lon': -118.11701}}, {'zip': '90807', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Renew Behavioral Health, Inc.', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '92506', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'CiTrials', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Institute of Living/Hartford Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Health System", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33122', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Premier Clinical Research Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32763', 'city': 'Orange City', 'state': 'Florida', 'country': 'United States', 'facility': 'Medical Research Group of Central Florida', 'geoPoint': {'lat': 28.94888, 'lon': -81.29867}}, {'zip': '30331', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Center for Medical Research', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'John Hopkins University - Hugo W Moser Research Institute at Kennedy Krieger Inc.', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts Medical School - Psychiatry Department', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '48105', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Clinical Research Institute', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55454', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota Medical Center - Department of Psychiatry', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '39232', 'city': 'Flowood', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Precise Research Centers', 'geoPoint': {'lat': 32.30959, 'lon': -90.13898}}, {'zip': '14618', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Finger Lakes Clinical Research', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati - Dept. of Psychiatry and Behavioral Neuroscience', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Case Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Focus and Balance LLC', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98011', 'city': 'Bothell', 'state': 'Washington', 'country': 'United States', 'facility': 'Pacific Institute of Medical Sciences', 'geoPoint': {'lat': 47.76232, 'lon': -122.2054}}, {'zip': '99352', 'city': 'Richland', 'state': 'Washington', 'country': 'United States', 'facility': 'Zain Research, LLC', 'geoPoint': {'lat': 46.28569, 'lon': -119.28446}}, {'city': 'New Taipei City', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital (Linkou)', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital (Taipei)', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Veteran General Hospital Taipei', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Robert Findling, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hugo W. Moser Research Institute at Kennedy Krieger, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SyneuRx International (Taiwan) Corp', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}