Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:00 PM
Study NCT ID:
NCT01519856
Status:
COMPLETED
Last Update Posted:
2016-01-29
First Post:
2010-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PIRLONG-PD Safety and Efficacy of Piribedil in Parkinson's Disease During Long Term Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D010891', 'term': 'Piribedil'}, {'id': 'D017336', 'term': 'Loratadine'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003533', 'term': 'Cyproheptadine'}, {'id': 'D003986', 'term': 'Dibenzocycloheptenes'}, {'id': 'D001567', 'term': 'Benzocycloheptenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 908}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-28', 'studyFirstSubmitDate': '2010-03-12', 'studyFirstSubmitQcDate': '2012-01-26', 'lastUpdatePostDateStruct': {'date': '2016-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Adverse event profile during long term therapy with piribedil in patients with Parkinson's disease", 'timeFrame': '4 years'}], 'secondaryOutcomes': [{'measure': 'Influence on quality of life', 'timeFrame': '4 years'}, {'measure': 'Quality of life parameters', 'timeFrame': '4 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['open', 'non-intervention', 'observational'], 'conditions': ["Parkinson's Disease"]}, 'referencesModule': {'references': [{'pmid': '16267842', 'type': 'BACKGROUND', 'citation': "Castro-Caldas A, Delwaide P, Jost W, Merello M, Williams A, Lamberti P, Aguilar M, Del Signore S, Cesaro P; Parkinson-Control Study Group. The Parkinson-Control study: a 1-year randomized, double-blind trial comparing piribedil (150 mg/day) with bromocriptine (25 mg/day) in early combination with levodopa in Parkinson's disease. Mov Disord. 2006 Apr;21(4):500-9. doi: 10.1002/mds.20750."}, {'pmid': '17013922', 'type': 'BACKGROUND', 'citation': "Rascol O, Dubois B, Caldas AC, Senn S, Del Signore S, Lees A; Parkinson REGAIN Study Group. Early piribedil monotherapy of Parkinson's disease: A planned seven-month report of the REGAIN study. Mov Disord. 2006 Dec;21(12):2110-5. doi: 10.1002/mds.21122."}, {'pmid': '15138753', 'type': 'BACKGROUND', 'citation': 'Peretti CS, Gierski F, Harrois S. Cognitive skill learning in healthy older adults after 2 months of double-blind treatment with piribedil. Psychopharmacology (Berl). 2004 Nov;176(2):175-81. doi: 10.1007/s00213-004-1869-8. Epub 2004 May 12.'}, {'pmid': '11903513', 'type': 'BACKGROUND', 'citation': 'Schuck S, Bentue-Ferrer D, Kleinermans D, Reymann JM, Polard E, Gandon JM, Allain H. Psychomotor and cognitive effects of piribedil, a dopamine agonist, in young healthy volunteers. Fundam Clin Pharmacol. 2002 Feb;16(1):57-65. doi: 10.1046/j.1472-8206.2002.00070.x.'}]}, 'descriptionModule': {'briefSummary': "Non-Ergot Dopamine agonists are meanwhile the drugs of first-choice in the treatment of Parkinson's disease. The receptor profile of the non-ergot dopamine-agonist piribedil is unique. In addition to agonistic effects on dopaminergic D2- and D3-receptors piribedil has adrenergic alpha-2A- and alpha-2C-receptors antagonisic properties. There is evidence from the literature that the antagonistic properties of piribedil are correlated with an improvement of cognitive function and vigilance parameters in parkinson's disease. The aim of the present non-interventional study is to investigate the safety and efficacy of piribedil during long-term therapy of patients with M. Parkinson under consideration of cognitive functions and quality of life."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'male and female patients with Morbus Parkinson', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* newly diagnosed or advanced idiopathic Parkinson's disease\n* male and female patients over 18 years of age\n* indication for treatment with piribedil according to Summary of Product Characteristics (SmPC)\n\nExclusion Criteria:\n\n* in line with piribedil SmPC\n* in particular hypersensitivity to piribedil or to any of the excipients and pregnancy and lactation as stated in the SmPC"}, 'identificationModule': {'nctId': 'NCT01519856', 'acronym': 'PIR-008/K', 'briefTitle': "PIRLONG-PD Safety and Efficacy of Piribedil in Parkinson's Disease During Long Term Therapy", 'organization': {'class': 'INDUSTRY', 'fullName': 'Desitin Arzneimittel GmbH'}, 'officialTitle': 'Efficacy and Safety of Long-term Therapy With Piribedil (CLARIUM) in Patients With M. Parkinson Under Consideration of Quality of Life Parameters and Cognitive Function', 'orgStudyIdInfo': {'id': 'PIR-008/K'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'tablet', 'interventionNames': ['Drug: piribedil (Clarium)']}], 'interventions': [{'name': 'piribedil (Clarium)', 'type': 'DRUG', 'description': 'oral tablets, 50 mg', 'armGroupLabels': ['tablet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71034', 'city': 'Böblingen', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Dr. Erich Scholz', 'geoPoint': {'lat': 48.68212, 'lon': 9.01171}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Desitin Arzneimittel GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}