Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-27 @ 2:16 AM
Study NCT ID:
NCT03433950
Status:
SUSPENDED
Last Update Posted:
2021-11-16
First Post:
2018-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Characteristics of Parkinson's Disease Subjects With Severe Hypertension During Motor OFFs.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D006973', 'term': 'Hypertension'}], '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': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'COVID-19 Research Restrictions', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2018-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-15', 'studyFirstSubmitDate': '2018-01-08', 'studyFirstSubmitQcDate': '2018-02-08', 'lastUpdatePostDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic Blood Pressure Change', 'timeFrame': 'Change in systolic blood pressure from 08:30 am measurement to 11:00 am measurement.', 'description': 'Blood pressure measurement taken at lowest "OFF" rating on the Unified Parkinson\'s Disease Rating Scale (UPDRS) and highest "ON" rating on the UPDRS.'}], 'secondaryOutcomes': [{'measure': 'Diastolic Blood Pressure Change', 'timeFrame': 'Change in systolic blood pressure from 08:30 am measurement to 11:00 am measurement.', 'description': 'Blood pressure measurement taken at lowest "OFF" rating on the Unified Parkinson\'s Disease Rating Scale (UPDRS) and highest "ON" rating on the UPDRS.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['antiparkinson'], 'conditions': ['Parkinson Disease', 'Hypertension', 'Antiparkinsonism Drugs Causing Adverse Effects in Therapeutic Use']}, 'referencesModule': {'references': [{'pmid': '6502182', 'type': 'RESULT', 'citation': "Baratti M, Calzetti S. Fluctuation of arterial blood pressure during end-of-dose akinesia in Parkinson's disease. J Neurol Neurosurg Psychiatry. 1984 Nov;47(11):1241-3. doi: 10.1136/jnnp.47.11.1241."}, {'pmid': '8264907', 'type': 'RESULT', 'citation': 'Chase TN, Mouradian MM, Engber TM. Motor response complications and the function of striatal efferent systems. Neurology. 1993 Dec;43(12 Suppl 6):S23-7.'}, {'pmid': '17388983', 'type': 'RESULT', 'citation': 'Pursiainen V, Korpelainen JT, Haapaniemi TH, Sotaniemi KA, Myllyla VV. Blood pressure and heart rate in parkinsonian patients with and without wearing-off. Eur J Neurol. 2007 Apr;14(4):373-8. doi: 10.1111/j.1468-1331.2007.01672.x.'}]}, 'descriptionModule': {'briefSummary': 'Current management of hypertension in PD motor fluctuators is flawed. The current practice often is to treat transient hypertensive spikes reported by patients or measured in clinics with anti-hypertensive medications. This may contribute to morbidity by worsening orthostatic hypotension and increasing fall risk. There is a scarcity of literature on this subject and there is no documentation of severe hypertension with rises in systolic blood pressure exceeding 50% of baseline occurring during motor "OFF". There are two studies that have demonstrated that blood pressure fluctuation can occur in motor fluctuators during the "OFF" state1,2. The study by Baratti et al measured blood pressure in 13 Parkinson\'s disease patients, 7 with motor fluctuations and 6 without fluctuations. In the fluctuators, the mean systolic/diastolic blood pressures were significantly higher than the non-fluctuators during the "OFF" state but not the "ON" state.', 'detailedDescription': 'This is an observational study. This study will only recruit Parkinson\'s subjects with rises in systolic blood pressure exceeding 50% of baseline during motor off periods to select for subjects with severe blood pressure fluctuations. The clinical characteristics, including but not limited to, the degree of change of the motor tapping score, during an "off" period of this group of subjects with severe hypertension. There is a screening visit, a at home monitoring period, and a one-time 4-8 hour study visit for subjects that satisfy the inclusion criteria. The screening visit will assess Parkinson\'s motor state and review the inclusion/exclusion criteria. The at home monitoring period will measure blood pressure twice a levodopa cycle for 5 cycles (for most subjects, this will be for two days and is dependent on the subject\'s clinical levodopa cycle). Measurements will occur pre-levodopa dose (the maximal "OFF" time), and half-way through the cycle (maximal "ON" time). The percentage of change will be calculated and those that have a systolic change of greater than or equal to 50% will proceed to the outpatient visit. The outpatient visit will measure blood pressure, pulse, Parkinson\'s motor symptoms, and plasma levodopa levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Parkinson's disease participants with motor fluctuations.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Idiopathic Parkinson\'s disease fulfilling UK Brain Bank clinical criteria.\n* Treatment with chronic levodopa (levodopa treatment for ≥ 3 years).\n* Rise in "OFF" systolic blood pressure exceeding 50% of baseline "ON" systolic blood pressure as shown by at home monitoring.\n* History of "wearing off" prior to 4 hours after the previous levodopa dose per patient report or chart documentation.\n\nExclusion Criteria:\n\n* Daily beta-blocker therapy.\n* Diabetes mellitus, autonomic neuropathy, or other condition known to alter autonomic functions.\n* Significant cognitive impairment as measured by the Montreal Cognitive Assessment score of \\< 16'}, 'identificationModule': {'nctId': 'NCT03433950', 'acronym': 'CLIN-HTN-PD', 'briefTitle': "Clinical Characteristics of Parkinson's Disease Subjects With Severe Hypertension During Motor OFFs.", 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': "Clinical Characteristics of Parkinson's Disease Subjects With Severe Hypertension During Motor OFFs.", 'orgStudyIdInfo': {'id': '17490'}, 'secondaryIdInfos': [{'id': 'VA IRB 4143', 'type': 'OTHER', 'domain': 'VA Portland Health System'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fluctuator', 'description': "Parkinson's subjects with rises in systolic blood pressure exceeding 50% of baseline during motor off periods to select for subjects with severe blood pressure fluctuations.", 'interventionNames': ['Other: No Intervention']}], 'interventions': [{'name': 'No Intervention', 'type': 'OTHER', 'description': 'Observational', 'armGroupLabels': ['Fluctuator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'VA Portland Health Care System', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prinicpal Investigator', 'investigatorFullName': 'Kathryn Anne Chung', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}