Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-02-20 @ 1:41 PM
Study NCT ID:
NCT01003002
Status:
WITHDRAWN
Last Update Posted:
2016-04-06
First Post:
2009-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Natural History of Levodopa-Induced Dyskinesia (LID)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009069', 'term': 'Movement 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': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007980', 'term': 'Levodopa'}], 'ancestors': [{'id': 'D004295', 'term': 'Dihydroxyphenylalanine'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014443', 'term': 'Tyrosine'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Funding not secured.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-04-04', 'studyFirstSubmitDate': '2009-10-27', 'studyFirstSubmitQcDate': '2009-10-27', 'lastUpdatePostDateStruct': {'date': '2016-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Levodopa-Induced Dyskinesia', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Parkinson's disease", 'Dyskinesia', 'Movement Disorders'], 'conditions': ["Parkinson's Disease"]}, 'referencesModule': {'references': [{'pmid': '17417738', 'type': 'RESULT', 'citation': "Muller T, Woitalla D, Russ H, Hock K, Haeger DA. Prevalence and treatment strategies of dyskinesia in patients with Parkinson's disease. J Neural Transm (Vienna). 2007;114(8):1023-6. doi: 10.1007/s00702-007-0718-4. Epub 2007 Apr 10."}, {'pmid': '11035889', 'type': 'RESULT', 'citation': 'Parkinson Study Group. Pramipexole vs levodopa as initial treatment for Parkinson disease: A randomized controlled trial. Parkinson Study Group. JAMA. 2000 Oct 18;284(15):1931-8. doi: 10.1001/jama.284.15.1931.'}, {'pmid': '10816186', 'type': 'RESULT', 'citation': "Rascol O, Brooks DJ, Korczyn AD, De Deyn PP, Clarke CE, Lang AE. A five-year study of the incidence of dyskinesia in patients with early Parkinson's disease who were treated with ropinirole or levodopa. N Engl J Med. 2000 May 18;342(20):1484-91. doi: 10.1056/NEJM200005183422004."}, {'pmid': '12112073', 'type': 'RESULT', 'citation': 'Nutt JG, Carter JH, Lea ES, Sexton GJ. Evolution of the response to levodopa during the first 4 years of therapy. Ann Neurol. 2002 Jun;51(6):686-93. doi: 10.1002/ana.10189.'}, {'pmid': '12465061', 'type': 'RESULT', 'citation': "McColl CD, Reardon KA, Shiff M, Kempster PA. Motor response to levodopa and the evolution of motor fluctuations in the first decade of treatment of Parkinson's disease. Mov Disord. 2002 Nov;17(6):1227-34. doi: 10.1002/mds.10244."}]}, 'descriptionModule': {'briefSummary': "Levodopa is the main drug treatment for Parkinson's disease. Levodopa can cause unwanted and uncontrolled movements called dyskinesias (LID). The severity of these movements can range from subtle to extremely debilitating. These movements may or may not interfere with normal activities such as putting on a coat or brushing ones teeth. Current estimates of the occurrence rate of LID range from 12 % to 100% after one year of levodopa treatment. These estimates used reporting mechanisms such as self-report and doctor-reported. These reporting mechanisms are not reliable. We will use an objective measure of dyskinesia in the first 5 years of treatment for Parkinson's disease. The purpose of this protocol is to use an objective measure to estimate dyskinesia onset.", 'detailedDescription': "Nearly all Parkinson's disease (PD) patients eventually develop abnormal and unwanted movements (dyskinesias; LID) caused by the gold standard treatment, Levodopa. The severity of these movements can range from subtle to extremely debilitating and may or may not interfere with normal activities such as putting on a coat or brushing ones teeth. Current estimates of the prevalence of LID widely range from 12 % to 100% affected after one year. The purpose of this study is to estimate the median onset time of levodopa induced dyskinesia in newly treated Parkinson's disease patients. All participants will complete seven overnight visits at the OCTRI Inpatient unit over 5 years. During the next day, participants will complete a mental task while standing on a force plate for one minute every half hour until the end of the study. A levodopa IV infusion will occur from 0900 to 1100."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Parkinson's disease", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of Parkinson's disease\n* At least 21 years of age\n* Levodopa treatment that will be orally initiated no more than 1 month after the screening visit for the study.\n\nExclusion Criteria:\n\n* Unable to stand for 1 minute intervals\n* Sensory deficits in the feet\n* Significant cognitive impairment\n* Unstable medical or psychiatric conditions (including hallucinations)\n* History of dopamine receptor blocking medications (Haldol, Orap, Zyprexa)"}, 'identificationModule': {'nctId': 'NCT01003002', 'briefTitle': 'Natural History of Levodopa-Induced Dyskinesia (LID)', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Determining the Natural History of Levodopa-Induced Dyskinesia (LID)', 'orgStudyIdInfo': {'id': 'e4773'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PD Cohort', 'description': "The cohort for this study is Parkinson's disease patients that are beginning oral levodopa treatment within one month of the screening visit. This cohort has not previously (to the screening visit) been treated with oral levodopa.", 'interventionNames': ['Drug: Levodopa (delivered intravenously)']}], 'interventions': [{'name': 'Levodopa (delivered intravenously)', 'type': 'DRUG', 'description': 'One mg/kg/hr of Levodopa will be given intravenously during inpatient testing days from 0900 to 1100.', 'armGroupLabels': ['PD Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Kathryn Chung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oregon Clinical and Translational Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Kathryn Chung, MD', 'oldOrganization': 'Oregon Health & Science University'}}}}