Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-27 @ 10:55 PM
Study NCT ID:
NCT00914134
Status:
COMPLETED
Last Update Posted:
2011-02-24
First Post:
2009-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Duodenal Levodopa Infusion, Quality of Life and Autonomic Nervous System 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': 'C009265', 'term': 'carbidopa, levodopa drug combination'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-23', 'studyFirstSubmitDate': '2009-06-01', 'studyFirstSubmitQcDate': '2009-06-03', 'lastUpdatePostDateStruct': {'date': '2011-02-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Orthostatic blood pressure change', 'timeFrame': 'Before levodopa infusion, after 3-5 days of levodopa infusion and 2 months after levodopa infusion was started'}], 'secondaryOutcomes': [{'measure': 'Sweating measured by evaporimeter', 'timeFrame': 'Before levodopa infusion, after 3-5 days of levodopa infusion, 2 months after levodopa infusion was started'}, {'measure': 'Autonomic nervous system symptoms questionnaire (NMSS)', 'timeFrame': 'Before levodopa infusion and 2 months after levodopa infusion was started'}, {'measure': 'Quality of life questionnaire (PDQ-39)', 'timeFrame': 'Before levodopa infusion and 2 months after levodopa infusion was started'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Parkinson's disease", 'Autonomic nervous system', 'Levodopa infusion'], 'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "The aim of the study is to assess the effect of continuous levodopa infusion on autonomic nervous system in patients with Parkinson's Disease (PD), blood pressure regulation and sweating. The investigators' hypothesis is that levodopa infusion may alleviate hyperhidrosis and orthostatic hypotension.", 'detailedDescription': "Parkinson's disease (PD) is one of the most common neurodegenerative disorders with increasing prevalence because of aging population. The main symptoms include rigidity, hypokinesia, tremor and impaired balance, but the disease also causes autonomic dysfunction. Motor fluctuations are common treatment related problems in PD, around 50-70% of patients treated with levodopa finally develop motor fluctuations. Continuous duodenal levodopa infusion has been effective in the treatment of motor dysfunction in advanced PD. However, little is known of its effects on autonomic nervous system."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of idiopathic Parkinson's disease: diagnosis made at least five years earlier\n* Positive response to levodopa\n* Motor fluctuations that cannot be adequately controlled with oral medication\n* No signs or symptoms of cerebellar dysfunction or vascular parkinsonism\n\nExclusion Criteria:\n\n* Severe cognitive symptoms\n* Glaucoma\n* Severe arrythmias\n* Severe asthma or COPD\n* Heart, liver or kidney failure\n* No significant vascular lesions in brain MRI imaging."}, 'identificationModule': {'nctId': 'NCT00914134', 'briefTitle': "Duodenal Levodopa Infusion, Quality of Life and Autonomic Nervous System in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University of Helsinki'}, 'officialTitle': "Effect of Duodenal Levodopa Infusion on Quality of Life and Autonomic Dysfunction in Patients With Parkinson's Disease", 'orgStudyIdInfo': {'id': 'PDAUT2009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Levodopa Infusion', 'description': "Patients with advanced Parkinson's disease and motor fluctuations that cannot be adequately controlled with oral medication.", 'interventionNames': ['Drug: Levodopa infusion']}], 'interventions': [{'name': 'Levodopa infusion', 'type': 'DRUG', 'otherNames': ['Duodopa'], 'description': 'Naso-duodenal infusion line is inserted in fluoroscopy control. Levodopa infusion is then tested approximately 5 days. If patient responds favorably to the treatment, PEG-infusion line is inserted in gastroscopy control and patient is followed in hospital for 2 to 4 days to ensure stability of the infusion line. The dosage is individually adjusted, starting dose is estimated from earlier oral levodopa dose.', 'armGroupLabels': ['Levodopa Infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00250', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Helsinki University Central Hospital, Department of Neurology', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'overallOfficials': [{'name': 'Eero Pekkonen, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Helsinki University Central Hospital, Department of Neurology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Helsinki', 'class': 'OTHER'}, 'collaborators': [{'name': 'Solvay Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Eero Pekkonen', 'oldOrganization': 'Helsinki University Central Hospital, Department of Neurology'}}}}