Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-30 @ 6:34 PM
Study NCT ID:
NCT01286935
Status:
COMPLETED
Last Update Posted:
2011-01-31
First Post:
2010-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
18-month Study of Long-term Efficacy & Safety of Safinamide as add-on Therapy in Patients With Mid-late Stage PD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-07-01', 'releaseDate': '2016-05-24'}], 'estimatedResultsFirstSubmitDate': '2016-05-24'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C092797', 'term': 'safinamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 544}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-28', 'studyFirstSubmitDate': '2010-08-23', 'studyFirstSubmitQcDate': '2011-01-28', 'lastUpdatePostDateStruct': {'date': '2011-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change in the dyskinesias rating scale (DRS) during "on" time', 'timeFrame': 'Up to 104 weeks (from baseline 016 to EOS study 018)', 'description': 'mean change in the dyskinesias rating scale (DRS) during "on" time from baseline (study 016) to endpoint (last visit in study 018).'}], 'secondaryOutcomes': [{'measure': "Endpoints include 'ON time', responder rates and UPDRS IV change", 'timeFrame': 'Up to 104 weeks (from baseline 016 to EOS study 018)', 'description': '* Chge in ON time (ON+ON minor dysk),\n* Diary Resp Rate at 12-m, 18 \\& 24 m on the ITT\\&mITT pop\\&pts who completed 2-yr period\n* UPDRS IV chge in total score,items 32-35 \\& 32-34\n* Time develop tblsome dysk(\\> 30min incr of tblsome dysk)\n* Time develop any (minor \\&/or tblsome) dysk (\\> 30 min incr of dysk)\n* Chge ADLs during ON, vs pbo(UPDRS II)\n* Maintenance of effect in UPDRS II "resp\'(resp \\>=20% impr in ADLs).\n\n * chge in L-dopa dose\n * chge in any PD(other than L-dopa)drug dose\n* Chge in UPDRS III, CGI-C and CGI-S\n* Chge in diary categories(ON, OFF, ON minor dysk, ON tblsome dysk, ASLEEP)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["Parkinson's Disease", 'PD', 'Levodopa', "Patients with idiopathic Parkinson's Disease with motor fluctuations,"], 'conditions': ["Parkinson's Disease"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.newron.com/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine the long-term efficacy and safety of two doses of safinamide (50 and 100 mg/day, p.o), compared to placebo, as add-on therapy in patients with idiopathic Parkinson's disease with motor fluctuations, who are currently receiving a stable dose of levodopa."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient completed 24 weeks of treatment in Study 016, or, if the patient discontinued prematurely, he/she returned for scheduled efficacy evaluations at Weeks 12 and 24, as part of the Retrieved Dropout (RDO) population.\n* The patient was compliant with taking study medication in Study 016.\n* The patient is willing to participate in the study and signed an approved Informed Consent form.\n\nExclusion Criteria:\n\n* The patient is experiencing clinically significant adverse events that would put the patient at risk for participating in the study.\n* The patient has shown clinically significant deterioration during participation in Study 016, and has reached Hoehn and Yahr Stage V.\n* The patient discontinued Study 016 prematurely for any reason, and did not return for scheduled efficacy evaluations at Weeks 12 and 24.'}, 'identificationModule': {'nctId': 'NCT01286935', 'briefTitle': '18-month Study of Long-term Efficacy & Safety of Safinamide as add-on Therapy in Patients With Mid-late Stage PD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Newron Pharmaceuticals SPA'}, 'officialTitle': 'A Phase III, Double-blind, Placebo-controlled, 18-mon Ext Study Long-term Efficacy & Safety of 50 & 100mg/Day Doses of Safinamide, as add-on Therapy, in Idiopathic PD Pts With Motor Fluctuations, Treated With Levodopa, Who May be Receiving DA, and/or Anticholinergic', 'orgStudyIdInfo': {'id': 'NW-1015/018/III/2006'}, 'secondaryIdInfos': [{'id': '2006-005861-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low Dose (50mg/day)', 'interventionNames': ['Drug: Safinamide']}, {'type': 'EXPERIMENTAL', 'label': 'High Dose (100mg/day)', 'interventionNames': ['Drug: Safinamide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Safinamide', 'type': 'DRUG', 'armGroupLabels': ['Low Dose (50mg/day)']}, {'name': 'Safinamide', 'type': 'DRUG', 'armGroupLabels': ['High Dose (100mg/day)']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'See Study 016 for details', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "PI's are the same as for study NW-1015/016/III/2006"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Newron Pharmaceuticals SPA', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dr Ravi Anand (Chief Medical Officer)', 'oldOrganization': 'Newron Pharmaceuticals S.p.A.'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-05-24', 'type': 'RELEASE'}, {'date': '2016-07-01', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Newron Pharmaceuticals SPA'}}}}