Clinical trial

Preventing Levodopa Induced Dyskinesia in Parkinson?s Disease With Statins

Name
NURE-004-18S
Description
In this study, the investigators will examine the association of statin use and dyskinesia in a convenience sample Parkinson's disease patients in the Veterans Administration Health Care System.
Trial arms
Trial start
2019-06-01
Estimated PCD
2026-07-01
Trial end
2027-03-31
Status
Recruiting
Treatment
Intravenous Infusion
Intravenous levodopa given 1.0 to 1.5 mg/kg/hr from 0930 - 1130 on a single visit day.
Arms:
No Statin, Statin After Levodopa, Statin Before Levodopa
Other names:
levodopa
Size
120
Primary endpoint
Peak Unified Dyskinesia Rating Score (UDysRS)
11:00 am
Eligibility criteria
Inclusion Criteria: * Parkinson's Disease * Age diagnosed with Parkinson's Disease greater than or equal to 50 years * Treatment with levodopa greater than or equal to 5 years Exclusion Criteria: * Deep Brain stimulation * Unable to stand for 1 minute intervals, or sensory deficits in the feet * Significant cognitive impairment as measured by the Montreal Cognitive Assessment score of \< 18 * Subjects with unstable medical or psychiatric conditions (including hallucinations). * History of unstable medical conditions (i.e. active cardiac disease, recent unwellness, surgery etc.) * Current use of drugs that may affect parkinsonism or dyskinesia: * dopamine receptor blocking medications * depakote * lithium * amiodarone * tetrabenazine * metoclopramide * dronabinol * and illicit drugs such as marijuana (THC) * cocaine * methamphetamine * Statins other than simvastatin or lovastatin, atorvastatin ie. fluvastatin (rationale is that while all other statins are thought to not cross the blood brain barrier well, the central nervous system penetrating nature of others is not perfectly clear and could confound results)
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'RETROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'plasma'}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}
Updated at
2023-07-13

1 organization

1 product

3 indications

Indication
Dyskinesia
Indication
Drug-induced