Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2026-04-07 @ 2:42 PM
Study NCT ID:
NCT02624167
Status:
COMPLETED
Last Update Posted:
2017-03-14
First Post:
2015-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Determine the Safety, Tolerability and Efficacy NW-3509A in Patients With Chronic Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-13', 'studyFirstSubmitDate': '2015-11-20', 'studyFirstSubmitQcDate': '2015-12-07', 'lastUpdatePostDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the safety and tolerability of NW-3509A in patients with schizophrenia on a stable dose of their current antipsychotic medication (aripiprazole or risperidone).', 'timeFrame': '27 days', 'description': 'To evaluate the safety and tolerability of NW-3509A given as an oral dose range of 30 to 50 mg/day (15 to 25 mg, BID) in patients with schizophrenia on a stable dose of their current antipsychotic medication (aripiprazole or risperidone).'}], 'secondaryOutcomes': [{'measure': 'Assessment of Positive and Negative Syndrome Scale (PANSS)', 'timeFrame': '27 days', 'description': 'Assessment of the PANSS - a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control, will be carried out at every visit'}, {'measure': 'Assessment of CGI-S (severity) and CGI-C (change)', 'timeFrame': '27 days; change from baseline', 'description': 'Measure of change from baseline will be done at every assessment'}, {'measure': 'Assessment of Strauss-Carpenter Level of Functioning (LOF) scale', 'timeFrame': '27 days; baseline and end of study', 'description': 'The LOF scale will be used at baseline and end of study, to evaluate the clinical outcome'}, {'measure': 'Measurement of plasma concentration Cmax', 'timeFrame': '27 days', 'description': 'Blood samples will be collected for PK evaluation at time points'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '8110442', 'type': 'BACKGROUND', 'citation': 'Addington D, Addington J, Maticka-Tyndale E. Assessing depression in schizophrenia: the Calgary Depression Scale. Br J Psychiatry Suppl. 1993 Dec;(22):39-44.'}, {'pmid': '12496955', 'type': 'BACKGROUND', 'citation': 'Casey DE, Daniel DG, Wassef AA, Tracy KA, Wozniak P, Sommerville KW. Effect of divalproex combined with olanzapine or risperidone in patients with an acute exacerbation of schizophrenia. Neuropsychopharmacology. 2003 Jan;28(1):182-92. doi: 10.1038/sj.npp.1300023.'}, {'pmid': '18537643', 'type': 'BACKGROUND', 'citation': 'Chahine M, Chatelier A, Babich O, Krupp JJ. Voltage-gated sodium channels in neurological disorders. CNS Neurol Disord Drug Targets. 2008 Apr;7(2):144-58. doi: 10.2174/187152708784083830.'}, {'pmid': '15949657', 'type': 'BACKGROUND', 'citation': 'Chouinard G, Margolese HC. Manual for the Extrapyramidal Symptom Rating Scale (ESRS). Schizophr Res. 2005 Jul 15;76(2-3):247-65. doi: 10.1016/j.schres.2005.02.013. Epub 2005 Apr 18.'}, {'pmid': '15021863', 'type': 'BACKGROUND', 'citation': 'Citrome L. Schizophrenia and valproate. Psychopharmacol Bull. 2003;37 Suppl 2:74-88.'}, {'type': 'BACKGROUND', 'citation': 'Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0, May 28, 2009 (v4.03 June 14, 2010), U.S. Department of Health and Human Services.'}, {'pmid': '24458010', 'type': 'BACKGROUND', 'citation': 'Crews KR, Gaedigk A, Dunnenberger HM, Leeder JS, Klein TE, Caudle KE, Haidar CE, Shen DD, Callaghan JT, Sadhasivam S, Prows CA, Kharasch ED, Skaar TC; Clinical Pharmacogenetics Implementation Consortium. Clinical Pharmacogenetics Implementation Consortium guidelines for cytochrome P450 2D6 genotype and codeine therapy: 2014 update. Clin Pharmacol Ther. 2014 Apr;95(4):376-82. doi: 10.1038/clpt.2013.254. Epub 2014 Jan 23.'}, {'type': 'BACKGROUND', 'citation': "Goldberg DP, Williams P. A User's Guide to the General Health Questionnaire. 1988. Windsor: NFER-Nelson."}, {'type': 'BACKGROUND', 'citation': 'Guy W (Ed). Clinical Global Impressions. In ECDEU Assessment Manual for Psychopharmacology, revised, U.S. Department of Health, Education and Welfare Pub. No. (ADM) 76-338. Rockville, MD: NIMH, 1976, 217-222.'}, {'pmid': '3616518', 'type': 'BACKGROUND', 'citation': 'Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261.'}, {'pmid': '16172203', 'type': 'BACKGROUND', 'citation': 'Lieberman JA, Stroup TS, McEvoy JP, Swartz MS, Rosenheck RA, Perkins DO, Keefe RS, Davis SM, Davis CE, Lebowitz BD, Severe J, Hsiao JK; Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Investigators. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med. 2005 Sep 22;353(12):1209-23. doi: 10.1056/NEJMoa051688. Epub 2005 Sep 19.'}, {'pmid': '19102711', 'type': 'BACKGROUND', 'citation': 'Llerena A, Dorado P, Penas-Lledo EM. Pharmacogenetics of debrisoquine and its use as a marker for CYP2D6 hydroxylation capacity. Pharmacogenomics. 2009 Jan;10(1):17-28. doi: 10.2217/14622416.10.1.17.'}, {'pmid': '17606655', 'type': 'BACKGROUND', 'citation': "Posner K, Oquendo MA, Gould M, Stanley B, Davies M. Columbia Classification Algorithm of Suicide Assessment (C-CASA): classification of suicidal events in the FDA's pediatric suicidal risk analysis of antidepressants. Am J Psychiatry. 2007 Jul;164(7):1035-43. doi: 10.1176/ajp.2007.164.7.1035."}, {'pmid': '25297512', 'type': 'BACKGROUND', 'citation': 'Stingl J, Viviani R. Polymorphism in CYP2D6 and CYP2C19, members of the cytochrome P450 mixed-function oxidase system, in the metabolism of psychotropic drugs. J Intern Med. 2015 Feb;277(2):167-177. doi: 10.1111/joim.12317.'}, {'pmid': '843175', 'type': 'BACKGROUND', 'citation': 'Strauss JS, Carpenter WT Jr. Prediction of outcome in schizophrenia. III. Five-year outcome and its predictors. Arch Gen Psychiatry. 1977 Feb;34(2):159-63. doi: 10.1001/archpsyc.1977.01770140049005.'}, {'pmid': '19186030', 'type': 'BACKGROUND', 'citation': 'Tiihonen J, Wahlbeck K, Kiviniemi V. The efficacy of lamotrigine in clozapine-resistant schizophrenia: a systematic review and meta-analysis. Schizophr Res. 2009 Apr;109(1-3):10-4. doi: 10.1016/j.schres.2009.01.002. Epub 2009 Jan 30.'}, {'pmid': '1593914', 'type': 'BACKGROUND', 'citation': 'Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.'}, {'pmid': '19817501', 'type': 'BACKGROUND', 'citation': 'Zhou SF. Polymorphism of human cytochrome P450 2D6 and its clinical significance: Part I. Clin Pharmacokinet. 2009;48(11):689-723. doi: 10.2165/11318030-000000000-00000.'}, {'pmid': '19902987', 'type': 'BACKGROUND', 'citation': 'Zhou SF. Polymorphism of human cytochrome P450 2D6 and its clinical significance: part II. Clin Pharmacokinet. 2009;48(12):761-804. doi: 10.2165/11318070-000000000-00000.'}]}, 'descriptionModule': {'briefSummary': 'A 4-week Phase IIa study to evaluate the safety and tolerability and efficacy of NW-3509A in patients with chronic schizophrenia that are not responding adequately to their current antipsychotic medication (aripiprazole or risperidone). NW-3509A is given as an oral dose range of 15 to 25 mg, BID in a 1:1 ratio.', 'detailedDescription': 'This is a prospective, 4-week, randomized, double-blind, placebo-controlled, study designed to evaluate the safety, tolerability, and preliminary efficacy of an oral dose range of NW-3509A of 30 to 50 mg/day (15 to 25 mg, BID) in patients with chronic schizophrenia on a stable dose of an antipsychotic (aripiprazole or risperidone). A minimum of 90 patients will be randomized in a 1:1 ratio to receive either NW-3509A (n=45) or placebo (n=45). Dose increases will be performed only during in-patient setting.\n\nSafety and efficacy assessments will be done on a weekly basis during the randomized treatment period. The assessment of safety will be based on laboratory tests (biochemistry, hematology, and urinalysis), 12-lead standard ECG, vital signs, physical examinations, neurological examinations, C-SSRS, ESRS-A, subjective reporting of any AE by the subject, objective observation of any AE by the Investigator. Pharmacokinetic samples will be taken at various time-points. Efficacy assessments will include the PANSS, CGI-C, CGI-S and the Strauss-Carpenter Level of Functioning (LOF) scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male/female; if female, must not of childbearing potential\n2. 18 to 65 years of age, inclusive;\n3. Has a current diagnosis of schizophrenia\n4. Has a total score on the PANSS \\< 75.\n5. Positive symptoms sub-scale score not to exceed 15; score of ≥4 on no more than 2 positive symptoms\n6. Has a Clinical Global Impression - Severity of disease (CGI-S) rating of mildly to moderately severely ill.\n7. Is in need of anti-psychotic treatment and is currently receiving a stable dose (minimally for 4 weeks prior to screening of oral risperidone or aripiprazole (at least 2 mg risperidone dose-equivalent).\n8. Current symptoms present for at least one month.\n9. Patient agrees to be hospitalized for up to 2 days at the start of dosing and at each dose increase'}, 'identificationModule': {'nctId': 'NCT02624167', 'briefTitle': 'A Study to Determine the Safety, Tolerability and Efficacy NW-3509A in Patients With Chronic Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Newron Pharmaceuticals SPA'}, 'officialTitle': 'A Phase IIA, Prospective, Randomized, Double-blind, Multiple-dose Study of NW-3509A in Chronic Schizoprhenia Patients Not Responding to Their Current Anti-psychotic Medication', 'orgStudyIdInfo': {'id': 'NW-3509A/002/II/2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'NW-3509A', 'description': 'Patients will start on NW-3509A 15 mg BID and be up-titrated to 20mg, and 25mg BID dependent on tolerability.', 'interventionNames': ['Drug: NW-3509A']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients will receive matching placebo BID', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'NW-3509A', 'type': 'DRUG', 'description': 'Patients will be given oral doses of 15, 20 and 25 mg BID of NW-3509A', 'armGroupLabels': ['NW-3509A']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Patients will be given oral dose of matching Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92845', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Collaborative Neuroscience Network.', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '08009', 'city': 'Berlin', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hassman Research Institute', 'geoPoint': {'lat': 39.79123, 'lon': -74.92905}}, {'zip': '600 040', 'city': 'Chennai', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'KHM Hospital', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'zip': '625020', 'city': 'Madurai', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Ahana Hospital', 'geoPoint': {'lat': 9.919, 'lon': 78.11953}}, {'zip': '560-029', 'city': 'Bangalore', 'country': 'India', 'facility': 'Tirthalli National Institute of Mental Health and Neurosciences', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}], 'overallOfficials': [{'name': 'Ravi Anand, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Newron Pharmaceuticals SPA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Newron Pharmaceuticals SPA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}