Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2025-12-25 @ 3:06 PM
Study NCT ID:
NCT03552068
Status:
COMPLETED
Last Update Posted:
2025-09-03
First Post:
2018-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Clonidine Efficacy for the Treatment of Impulse Control Disorders in Parkinson's Disease:
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D007174', 'term': 'Disruptive, Impulse Control, and Conduct Disorders'}], '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'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003000', 'term': 'Clonidine'}], 'ancestors': [{'id': 'D048288', 'term': 'Imidazolines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2018-05-17', 'studyFirstSubmitQcDate': '2018-06-08', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "QUIP-RS (Questionnaire for Impulsive-Compulsive Disorders in Parkinson's disease - Rating Scale)", 'timeFrame': 'at 8 weeks', 'description': 'Diminution of impulse control disorder severity on the initial more elevated sub-score of the QUIP-RS between the first visit and the eighth week under clonidine.\n\nDiminution of impulse control disorder severity on the initial more elevated sub-score of the QUIP-RS between the first visit and the eighth week under clonidine.\n\nDiminution of impulse control disorder severity on the initial more elevated sub-score of the QUIP-RS between the first visit and the eighth week under clonidine.'}], 'secondaryOutcomes': [{'measure': 'MDS-UPDRS', 'timeFrame': 'at 4 and 8 weeks', 'description': 'The Movement Disorder Society Unified Parkinson Disease Rating'}, {'measure': 'STAI', 'timeFrame': 'at 4 and 8 weeks', 'description': 'State-Trait Anxiety Index'}, {'measure': 'BDI II', 'timeFrame': 'at 4 and 8 weeks', 'description': 'Beck Depression Inventory II It is a self-administered questionnaire each of them using a four-point ordinal scoring system. For the summary index the scores were standardized from 1 to 40, so that higher scores indicate higher depression.'}, {'measure': 'ECMP scores', 'timeFrame': 'at 4 and 8 weeks', 'description': "Behavior evaluation of Parkinson's patients It is a self-administered questionnaire each of them using a four-point ordinal scoring system. For the summary index the scores were standardized from 1 to 40, so that higher scores indicate higher depression."}, {'measure': 'QUIP-RS sub-scores', 'timeFrame': 'at 4 weeks', 'description': "Questionnaire for Impulsive-Compulsive Disorders in Parkinson's disease - Rating Scale Diminution of impulse control disorder severity on the initial more elevated sub-score of the QUIP-RS between the first visit and the fourth weeks under clonidine.\n\nIt is a self-administered questionnaire. For the summary index the scores were standardized from 1 to 112, so that higher scores indicate higher Impulse control disorder. The sub score are standardized between 0 and 16."}, {'measure': 'QUIP-RS total score', 'timeFrame': 'at 4 and 8 weeks', 'description': 'Evolution of QUIP-RS total score and sub-scores Diminution of impulse control disorder severity on total score of the QUIP-RS between the first visit, the fourth and the eighth weeks under clonidine.\n\nIt is a self-administered questionnaire. For the summary index the scores were standardized from 1 to 112, so that higher scores indicate higher Impulse control disorder.'}, {'measure': 'PDQ 39 scale (Parkinson Disease Quotation)', 'timeFrame': 'at 4 and 8 weeks', 'description': 'It is a self-administered questionnaire comprised of 39 questions, each of them using a five-point ordinal scoring system, from which a single summary index can be calculated. For the summary index the scores were standardized from 0 to 100, so that higher scores indicate poorer quality of life.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Parkinson's disease", 'Impulse control disorder', 'Clonidine', 'Noradrenergic system'], 'conditions': ["Parkinson's Disease", 'Mpulse Control Disorders']}, 'referencesModule': {'references': [{'pmid': '37338615', 'type': 'BACKGROUND', 'citation': "Laurencin C, Timestit N, Marques A, Duchez DD, Giordana C, Meoni S, Huddlestone M, Danaila T, Anheim M, Klinger H, Vidal T, Fatisson M, Caire C, Nourredine M, Boulinguez P, Dhelens C, Ballanger B, Prange S, Bin S, Thobois S. Efficacy and safety of clonidine for the treatment of impulse control disorder in Parkinson's disease: a multicenter, parallel, randomised, double-blind, Phase 2b Clinical trial. J Neurol. 2023 Oct;270(10):4851-4859. doi: 10.1007/s00415-023-11814-y. Epub 2023 Jun 20."}]}, 'descriptionModule': {'briefSummary': "Noradrenergic system is involved in impulsivity in the general population and is altered in Parkinson's disease (PD) in the early stages of the disease. Thus, targeting this system could be of interest in impulse control disorder (ICD). Acting on the noradrenergic system is possible using clonidine, an α2 adrenergic agonist largely used in hypertension treatment and that induces a decrease of NADR release. Thus, our aim is to conduct a proof of concept study evaluating the efficacy and safety of clonidine on ICD in PD. This study is a multicenter, randomized, double-blind, placebo-controlled in parallel group clinical trial."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with PD according to MDS (movement disorders society) criteria for at least one year\n* Patients with ICD with a QUIP-RS score ≥10 and/or at least one of the sub-scores in the following range: Pathological gambling between \\>6 and 12; Pathological gambling between \\>8 and 12; Hypersexuality between \\> 8 and 12; Eating between \\> 7 and 12. The use of "lower" margins will guarantee that patients will present behavioral disturbances severe enough to justify clonidine treatment. On the other hand, the use of "upper" margins will guarantee that the patients included in the trial will not suffer from ICD too severe to ethically participate to a placebo controlled study.\n* Weight between 40 and 95kg\n* Stable antiparkinsonian medication since at least 2 months before randomization and medication supposed to remain stable during the study\n* ICD onset after Parkinson\'s disease onset and after initiation of dopaminergic drugs\n* No signs of dementia (Montreal Cognitive Assessment, MOCA \\>20);\n* No lactose intolerance which may compromise the tolerance of the placebo;\n* Patients with health insurance\n* Patients without judicial protection measure except directly linked to ICD\n* For women of childbearing potential, an effective contraception method for at least 2 months before randomization (as implants or oral oestro-progestative contraceptives), condom use for men during the study. βHCG dosage in urine should be negative at randomization for women.\n\nExclusion Criteria:\n\nPatients with major depression (BDI \\>19);\n\n* Patients with another parkinsonian syndrome (Parkinson "plus" or vascular Parkinsonism)\n* Orthostatic hypotension\n* Patients with swallowing disorders that may prevent oral medication,\n* Contraindication to clonidine: Hypersensibility; Severe bradyarythmia due to a cardiac disease\n* Patients receiving a treatment potentially interacting with clonidine\n* Patients with Raynaud\'s disease or obliterating thromboangiitis\n* Patients With Heart failure or severe coronary artery disease\n* Patients with a drug treatment having a potential interaction with clonidine (see list, appendix 2);\n* Presence of renal failure (Cockcroft-Gault at inclusion visit\\<30 ml/min/1,73m2);\n* Patients with a present or past history of addiction (apart ICD) or with a substance abuse (except Tabaco)\n* Pregnant or lactating women\n* Already participating in another biomedical research project'}, 'identificationModule': {'nctId': 'NCT03552068', 'acronym': 'ID-CLO', 'briefTitle': "Study of Clonidine Efficacy for the Treatment of Impulse Control Disorders in Parkinson's Disease:", 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': "Study of Clonidine Efficacy for the Treatment of Impulse Control Disorders in Parkinson's Disease: A Pilot Double Blind Randomized Trial", 'orgStudyIdInfo': {'id': '69HCL18_0135'}, 'secondaryIdInfos': [{'id': '2019-000165-20', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Patients under placebo', 'description': 'Treatment will be taken during 8 weeks with one visit at 2, 4 and 8 weeks. The usual antiparkinsonian treatment of the patient should remain stable throughout the 8 weeks.', 'interventionNames': ['Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patient under clonidine', 'description': 'Treatment will be taken during 8 weeks with one visit at 2, 4 and 8 weeks. The usual antiparkinsonian treatment of the patient should remain stable throughout the 8 weeks.', 'interventionNames': ['Drug: Clonidine']}], 'interventions': [{'name': 'placebo', 'type': 'DRUG', 'description': 'Treatment (placebo) will be taken during 8 weeks with one visit at 2, 4 and 8 weeks.\n\nMedication: placebo twice a day (in the morning and evening).', 'armGroupLabels': ['Patients under placebo']}, {'name': 'Clonidine', 'type': 'DRUG', 'description': 'Treatment will be taken during 8 weeks with one visit at 2, 4 and 8 weeks. Medication: 75 μg of clonidine twice a day (in the morning and evening).', 'armGroupLabels': ['Patient under clonidine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bron', 'country': 'France', 'facility': 'Hospices Civils de Lyon', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}], 'overallOfficials': [{'name': 'LAURENCIN Chloé, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}