Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2026-01-03 @ 8:06 PM
Study NCT ID:
NCT01765257
Status:
UNKNOWN
Last Update Posted:
2013-01-10
First Post:
2013-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053609', 'term': 'Lethargy'}], 'ancestors': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C031967', 'term': 'rasagiline'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2015-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-01-09', 'studyFirstSubmitDate': '2013-01-08', 'studyFirstSubmitQcDate': '2013-01-09', 'lastUpdatePostDateStruct': {'date': '2013-01-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lille Apathy Rating Scale (LARS) score', 'timeFrame': 'at the visit 3 (after 3 months of treatment)'}], 'secondaryOutcomes': [{'measure': "Motor assessment : Unified Parkinson's Disease Rating Scale", 'timeFrame': 'at the visit 3 (after 3 months of treatment)'}, {'measure': 'Depressive and anxiety symptoms : MADRS + Hamilton anxiety scale', 'timeFrame': 'at the visit 3 (after 3 months of treatment)'}, {'measure': 'Self assessment of apathy : Starkstein', 'timeFrame': 'at the visit 3 (after 3 months of treatment)'}, {'measure': 'Quality of life : PDQ 39', 'timeFrame': 'at the visit 3 (after 3 months of treatment)'}, {'measure': 'Cognitive assessment: MATTIS dementia rating scale, MMSE, executive functions battery', 'timeFrame': 'at the visit 3 (after 3 months of treatment)'}, {'measure': "Hyperdopaminergic symptoms : Parkinson's disease behavioral scale", 'timeFrame': 'at the visit 3 (after 3 months of treatment)'}, {'measure': 'Fatigue assessment : Parkinson Fatigue Scale', 'timeFrame': 'at the visit 3 (after 3 months of treatment)'}]}, 'conditionsModule': {'keywords': ["Drug-naïve patients with Parkinson's disease", 'Apathy', 'Rasagiline'], 'conditions': ["Drug-naïve Patients With Parkinson's Disease", 'Apathy']}, 'descriptionModule': {'briefSummary': 'Among the psychiatric symptoms observed in the premotor phase of Parkinson\'s disease (PD) and/or in "de novo" patients, apathy is relatively frequent (estimated to 23%). However, the neuropathological bases of apathy are still unknown. However, recent data suggests that apathy could be linked to a more specific dopaminergic denervation in the ventral striatum.\n\nRasagiline increases the bioavailability of striatal endogenous dopamine by blocking the MAO-B. Some recent data suggest rasagiline could be effective to improve apathy in Parkinson\'s disease.\n\nThe primary outcome is to demonstrate a significant reduction of apathy using the Lille apathy rating scale (LARS) in drug naive patients with early diagnosed Parkinson\'s disease, using a treatment by rasagiline.', 'detailedDescription': "Study design :\n\nRandomized, double-blind, rasagiline (1 mg) vs placebo study. Parallel group (randomization 1/1). Duration 3 months 16 recruiting centers in France\n\nPopulation :\n\n50 drug-naïve patients with Parkinson's disease, with apathy. 2 groups : 25 patients with placebo and 25 patients with rasagiline.\n\n3 visits\n\n* Visit 1 : inclusion / randomisation/ first study medication dispensation\n* Visit 2 (1.5 month after V1) : first evaluation and second study medication dispensation.\n* Visit 3 (3 months after V1, final visit) : second evaluation"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- Drug-naïve patients with Parkinson's disease (UKPDBB criteria)\n\n* No dementia (Mattis dementia rating scale \\> 130; Mini Mental Sate Examination ≥26)\n* No depression (MADRS \\< 15)\n* Criteria of apathy from Robert et al (2009)\n* At least mild apathy (≥-21 to Lille Apathy Rating Scale)\n* Age : 35-70 y\n* Affiliation to social security\n* Agreement of patients\n\nExclusion Criteria:\n\n* \\- Any antiparkinsonian treatment (L.dopa, dopamine agonists, MAO-B-I, amantadine, anticholinergics). Patients treated by dopamine agonists but who have stopped it more than 3 months before their inclusion can be included.\n* Ongoing severe psychiatric or somatic diseases\n* Others treatments :\n* antipsychotics\n* antidepressants and anxiolytics (exclusion if the treatment is not stable the month before inclusion)\n* psychostimulants (methylphenidate, adrafinil, modafinil, deanol, vitamin C, sulbutiamine, glutamic acid, aspartic acid)\n* any contra-indication according to SmPC\n* patients under guardianship\n* Women without efficient contraception\n* Person who participate to an other study"}, 'identificationModule': {'nctId': 'NCT01765257', 'briefTitle': "Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center Study", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': "Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Study.", 'orgStudyIdInfo': {'id': 'CHU-0138'}, 'secondaryIdInfos': [{'id': '2007-002800-16'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rasagiline', 'description': 'Randomized, double-blind, rasagiline (1 mg) vs placebo study. Parallel group (randomization 1/1). Duration 3 months 16 recruiting centers in France', 'interventionNames': ['Drug: AZILECT®']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Randomized, double-blind, rasagiline (1 mg) vs placebo study. Parallel group (randomization 1/1). Duration 3 months 16 recruiting centers in France', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AZILECT®', 'type': 'DRUG', 'armGroupLabels': ['rasagiline']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'contacts': [{'name': 'Patrick LACARIN', 'role': 'CONTACT', 'email': 'placarin@chu-clermontferrand.fr', 'phone': '04 73 75 11 95'}], 'facility': 'CHU Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'centralContacts': [{'name': 'Patrick LACARIN', 'role': 'CONTACT', 'email': 'placarin@chu-clermontferrand.fr', 'phone': '04 73 75 11 95'}], 'overallOfficials': [{'name': 'Denis PEZET', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'collaborators': [{'name': 'H. Lundbeck A/S', 'class': 'INDUSTRY'}, {'name': 'CHU Purpan (Toulouse)', 'class': 'UNKNOWN'}, {'name': 'Hôpital Haut-Lévêque', 'class': 'OTHER'}, {'name': 'Centre Hospitalier de la côte Basque', 'class': 'OTHER'}, {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, {'name': 'CHU de Rennes (Rennes)', 'class': 'UNKNOWN'}, {'name': 'University Hospital, Lille', 'class': 'OTHER'}, {'name': 'Hôpital Dupuytren', 'class': 'OTHER'}, {'name': 'University Hospital, Caen', 'class': 'OTHER'}, {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, {'name': "Centre Hospitalier du Pays d'Aix", 'class': 'OTHER'}, {'name': 'Hôpital de la Timone (MARSEILLE)', 'class': 'UNKNOWN'}, {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, {'name': 'Fondation Rothschild Paris', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}