Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-28 @ 8:34 AM
Study NCT ID:
NCT01564992
Status:
UNKNOWN
Last Update Posted:
2018-08-13
First Post:
2012-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Interaction With Genes in Parkinson's Disease
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': 'D011110', 'term': 'Polymorphism, Genetic'}, {'id': 'D006239', 'term': 'Haplotypes'}], 'ancestors': [{'id': 'D014644', 'term': 'Genetic Variation'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}, {'id': 'D005838', 'term': 'Genotype'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-10', 'studyFirstSubmitDate': '2012-02-23', 'studyFirstSubmitQcDate': '2012-03-26', 'lastUpdatePostDateStruct': {'date': '2018-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All complications of the disease or treatment', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Parkinson's disease", 'Pharmacogenetics', 'Genetics'], 'conditions': ["Parkinson's Disease"]}, 'referencesModule': {'references': [{'pmid': '30862454', 'type': 'DERIVED', 'citation': "Marques A, Vidal T, Pereira B, Benchetrit E, Socha J, Pineau F, Elbaz A, Artaud F, Mangone G, You H, Cormier F, Galitstky M, Pomies E, Rascol O, Derkinderen P, Weintraub D, Corvol JC, Durif F; DIGPD study group. French validation of the questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS). Parkinsonism Relat Disord. 2019 Jun;63:117-123. doi: 10.1016/j.parkreldis.2019.02.026. Epub 2019 Mar 4."}, {'pmid': '29925549', 'type': 'DERIVED', 'citation': 'Corvol JC, Artaud F, Cormier-Dequaire F, Rascol O, Durif F, Derkinderen P, Marques AR, Bourdain F, Brandel JP, Pico F, Lacomblez L, Bonnet C, Brefel-Courbon C, Ory-Magne F, Grabli D, Klebe S, Mangone G, You H, Mesnage V, Lee PC, Brice A, Vidailhet M, Elbaz A; DIGPD Study Group. Longitudinal analysis of impulse control disorders in Parkinson disease. Neurology. 2018 Jul 17;91(3):e189-e201. doi: 10.1212/WNL.0000000000005816. Epub 2018 Jun 20.'}]}, 'descriptionModule': {'briefSummary': 'This observational study aims at identifying gene modifiers of Parkinson Disease (PD) and of treatment response and adverse events of antiparkinsonian drugs. Six hundred PD patients will be followed annually for up to 5 years. A biological collection will be associated with a full clinical assessment of motor and non motor symptoms, medical and treatment history, environmental factors. The association between candidate gene polymorphisms and disease or treatment complications will be analyzed.', 'detailedDescription': 'Title : Drug interaction with genes in Parkinson Disease\n\nObjective:\n\nTo identify genes associated to disease and treatment complication and response.\n\nNumber of subjects: 500\n\nStudy duration : 6 years\n\nDesign:\n\nProspective cohort with biological collection\n\nPrimary objective:\n\nIdentification of genes which polymorphism or haplotype is associated with a complication of Parkinson disease, directly or with the interaction of treatment.\n\nSecondary objectives:\n\n* Prevalence and incidence of disease or treatment complications\n* Clinical risk factor for disease or treatment complications\n* Biomarkers of disease progression, disease or treatment complications'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men and women adults with a Parkinson Disease according to UKPDSBB criteria, diagnosed \\< 6 years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women, age \\> 18.\n* Parkinson Disease according to UKPDSBB criteria\n* PD diagnosis \\< 6 years\n* Informed consent\n\nExclusion Criteria:\n\n\\- Atypical parkinsonism'}, 'identificationModule': {'nctId': 'NCT01564992', 'acronym': 'DIGPD', 'briefTitle': "Drug Interaction With Genes in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': "Drug Interaction With Genes in Parkinson's Disease", 'orgStudyIdInfo': {'id': 'P 071240'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Parkinson disease', 'description': 'Identification of genes', 'interventionNames': ['Other: Identification of genes']}], 'interventions': [{'name': 'Identification of genes', 'type': 'OTHER', 'otherNames': ['polymorphism or haplotype'], 'description': 'Identification of genes which polymorphism or haplotype is associated with a complication of Parkinson disease, directly or with the interaction of treatment.', 'armGroupLabels': ['Parkinson disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Christophe Corvol, MD, PhD', 'role': 'CONTACT', 'phone': '+33 1 42 16 57 66'}, {'name': 'Jean-Christophe Corvol, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Centre d'Investigation Clinique Neuro - Bâtiment ICM - Hôpital Pitié-Salpêtrière", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Jean-Christophe Corvol, MD, PhD', 'role': 'CONTACT', 'phone': '+33 1 42 16 57 66'}], 'overallOfficials': [{'name': 'Jean-Christophe Corvol, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asssitance Publique - Hopitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}