NCT04064294|CompletedResultsDMCFDA Drug
Preventing Levodopa Induced Dyskinesia in Parkinson's Disease With HMG-CoA Reductase Inhibitors
STAT-PD
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Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Oregon Health and Science University
OTHER · VA Portland Health Care System
OTHER · Oregon Clinical & Translational Research Institute
OTHER · VA Portland Health Care System (IRBNet)
observational
93
1 country
3
Study Start
August 22, 2019
Actual (reported)Primary Completion
March 31, 2024
Actual (reported)Study Completion
March 31, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2024
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 19, 2019
Actual (reported)August 21, 2019
Actual (reported)August 22, 2019
Actual (reported)March 31, 2024
Actual (reported)March 31, 2024
Actual (reported)April 11, 2025
Actual (reported)Peak Unified Dyskinesia Rating Score (UDysRS)
The Unified Dyskinesia Rating Scale (UDysRS) combines patient, caregiver, and treating physician perspectives on both historical (Parts 1 \& 2) and objective (Part 3 \& 4) assessments of dyskinesia and dystonia. The historical portion and the objective ratings are added together to form total score ranging from 0 to 104 with higher scores indicating more severe dyskinesia.
11:00 am
Peak Unified Dyskinesia Rating Scale - Objective Measures
11:00 am
Presence/Absence of Levodopa-induced Dyskinesia (LID).
Every half hour from 0900 to 1500
Clinical Dyskinesia Rating Scale (Peak)
11:00 am
Historical use of a statin BEFORE beginning levodopa
Historical use of a statin AFTER beginning levodopa
No historical use of a statin
Intravenous levodopa given 1.0 to 1.5 mg/kg/hr from 0930 - 1130 on a single visit day.
Parkinson's Disease
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97207-2964, United States
Oregon Health & Science University
Portland, Oregon, 97239not, United States
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108, United States
Obeso JA, Rodriguez-Oroz MC, Rodriguez M, DeLong MR, Olanow CW. Pathophysiology of levodopa-induced dyskinesias in Parkinson's disease: problems with the current model. Ann Neurol. 2000 Apr;47(4 Suppl 1):S22-32; discussion S32-4.
Tison F, Negre-Pages L, Meissner WG, Dupouy S, Li Q, Thiolat ML, Thiollier T, Galitzky M, Ory-Magne F, Milhet A, Marquine L, Spampinato U, Rascol O, Bezard E. Simvastatin decreases levodopa-induced dyskinesia in monkeys, but not in a randomized, placebo-controlled, multiple cross-over ("n-of-1") exploratory trial of simvastatin against levodopa-induced dyskinesia in Parkinson's disease patients. Parkinsonism Relat Disord. 2013 Apr;19(4):416-21. doi: 10.1016/j.parkreldis.2012.12.003. Epub 2012 Dec 31.
plasma
Type II statins became more popular in use during the course of the study, which led to recruitment difficulties initially and a pivot to allowing most all statin drugs.
Kathryn Anne Chung, MD
VA Portland Health Care System, Portland, OR
93 participants (actual enrollment reported by the registry).
First Submitted
August 19, 2019
First Posted
August 21, 2019
Study Start
August 22, 2019
Actual (reported)Riluzole to Treat Parkinson's Disease
Contact the study team to confirm eligibility.
Pavon N, Martin AB, Mendialdua A, Moratalla R. ERK phosphorylation and FosB expression are associated with L-DOPA-induced dyskinesia in hemiparkinsonian mice. Biol Psychiatry. 2006 Jan 1;59(1):64-74. doi: 10.1016/j.biopsych.2005.05.044. Epub 2005 Sep 1.
Primary Completion
March 31, 2024
Actual (reported)Study Completion
March 31, 2024
Actual (reported)Last Updated
April 11, 2025
Results First Posted
April 11, 2025
Record last verified: 2025-04
Individual participant data be available (including data dictionaries). Individual participant data that underlie the results reported the resultant article, after deidentification (text, tables, figures, and appendices). In addition to data, the study protocol and the informed consent form (ICF) will be provided. Data will be available beginning 6 months and ending 2 years following article publication. Data will be shared with Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. Data will be released to achieve aims in the approved proposal or for individual participant data meta-analysis. Proposals may be submitted up to 24 months following article publication. After 24 months the data will be available in the investigators' VA'S data repository but without investigator support other than deposited metadata.
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Source: ClinicalTrials.gov.
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