Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2026-01-05 @ 5:16 PM
Study NCT ID:
NCT01385592
Status:
COMPLETED
Last Update Posted:
2020-12-23
First Post:
2011-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy and Safety of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}], 'ancestors': [{'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C581397', 'term': 'mavoglurant'}]}}, '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': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'dispFirstSubmitDate': '2016-03-22', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-15', 'studyFirstSubmitDate': '2011-06-28', 'dispFirstSubmitQcDate': '2016-03-22', 'studyFirstSubmitQcDate': '2011-06-29', 'dispFirstPostDateStruct': {'date': '2016-04-25', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-12-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anti-dyskinetic efficacy as measured by the modified AIMS (Abnormal Involuntary Movement Scale) total score. To assess how titration of AFQ056 at 2-week intervals affects tolerability profile', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Anti-dyskinetic efficacy as measured by the Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS)', 'timeFrame': '12 weeks'}, {'measure': "Change from baseline on patient's disability caused by the dyskinesia as assessed by a clinician-rated global impression of change (CGIC)", 'timeFrame': '12 weeks'}, {'measure': 'Total ON- and OFF-times and ON-time with dyskinesia and with troublesome dyskinesias (patient diary)', 'timeFrame': '12 weeks'}, {'measure': "Anti-dyskinetic efficacy as measured by items 32, 33 and 34 of Part IV of the Unified Parkinson's Disease Rating Scale (UPDRS )", 'timeFrame': '12 weeks'}, {'measure': 'Safety of AFQ056 as measured by changes in vital signs, laboratory values, electrocardiogram and number of Adverse Events', 'timeFrame': '12 weeks'}]}, 'conditionsModule': {'keywords': ['Parkinson Disease', 'L-dopa', 'Levodopa', 'Dyskinesia', 'Anti-Dyskinesia Agents'], 'conditions': ['Dyskinesias', 'Parkinson Disease', 'Movement Disorders', 'Parkinsonian Disorders']}, 'referencesModule': {'references': [{'pmid': '27214258', 'type': 'DERIVED', 'citation': "Trenkwalder C, Stocchi F, Poewe W, Dronamraju N, Kenney C, Shah A, von Raison F, Graf A. Mavoglurant in Parkinson's patients with l-Dopa-induced dyskinesias: Two randomized phase 2 studies. Mov Disord. 2016 Jul;31(7):1054-8. doi: 10.1002/mds.26585. Epub 2016 May 23."}], 'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=9863', 'label': 'Results for CAFQ056A2222 from the Novartis Clinical Trials website'}]}, 'descriptionModule': {'briefSummary': "This study will assess the efficacy and safety of AFQ056 in patients that have Parkinson's Disease L-dopa Induced Dyskinesias (PD-LID)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Outpatients with Parkinson's disease (PD), treated with L-Dopa, experiencing dyskinesias for at least three months\n* Outpatients who are on a stable anti-parkinsonian treatment regimen for at least four weeks\n\nExclusion Criteria:\n\n* Surgical treatment for PD\n* Cancer within the past 5 years (other than localized skin cancer and prostate cancer that has been effectively treated)\n* Advanced, severe or unstable disease (other than PD) or evidence of dementia that may interfere with the study outcome evaluations\n\nOther protocol-defined inclusion/exclusion criteria may apply"}, 'identificationModule': {'nctId': 'NCT01385592', 'briefTitle': "Evaluation of the Efficacy and Safety of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias", 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': "12-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease", 'orgStudyIdInfo': {'id': 'CAFQ056A2222'}, 'secondaryIdInfos': [{'id': '2011-002073-30', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AFQ056 100 mg', 'interventionNames': ['Drug: AFQ056']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AFQ056', 'type': 'DRUG', 'armGroupLabels': ['AFQ056 100 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94089', 'city': 'Sunnyvale', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.36883, 'lon': -122.03635}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': 'N6A 4G5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'J9J 0A5', 'city': 'Gatineau', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.47723, 'lon': -75.70164}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '33604', 'city': 'Pessac', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '14547', 'city': 'Beelitz-Heilstätten', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.25965, 'lon': 12.92662}}, {'zip': '12163', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '44791', 'city': 'Bochum', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '40225', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '34128', 'city': 'Kassel', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.31667, 'lon': 9.5}}, {'zip': '04103', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '80804', 'city': 'München', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '81675', 'city': 'München', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '07646', 'city': 'Stadtroda', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.85684, 'lon': 11.72677}}, {'zip': '26655', 'city': 'Westerstede/Oldenburg', 'country': 'Germany', 'facility': 'Novartis Investigative Site'}, {'zip': '1085', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '7400', 'city': 'Kaposvár', 'country': 'Hungary', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 46.36667, 'lon': 17.8}}, {'zip': 'H-6725', 'city': 'Szeged', 'country': 'Hungary', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'zip': '39100', 'city': 'Bolzano', 'state': 'BZ', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 46.49067, 'lon': 11.33982}}, {'zip': '56126', 'city': 'Pisa', 'state': 'PI', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'zip': '00163', 'city': 'Roma', 'state': 'RM', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '08190', 'city': 'Sant Cugat del Vallès', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.47063, 'lon': 2.08611}}, {'zip': '08036', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '20014', 'city': 'Donostia / San Sebastian', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.31283, 'lon': -1.97499}}, {'zip': '28006', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}