N/A
N=80
Preventing Levodopa Induced Dyskinesia in Parkinson's Disease With HMG-CoA Reductase Inhibitors
Parkinson Disease · Dyskinesia, Drug-Induced
Bottom Line
View on ClinicalTrials.gov: NCT04064294 ↗Enrolled (actual)
80
Serious AEs
6.3%
Results posted
Apr 2025
Primary outcome: Primary: Peak Unified Dyskinesia Rating Score (UDysRS) — 10.9; 10.8; 13.2 score on a scale — p=0.63
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Intravenous Infusion (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Unified Dyskinesia Rating Score (UDysRS) |
10.9; 10.8; 13.2 | 0.63 |
| SECONDARY Peak Unified Dyskinesia Rating Scale - Objective Measures |
5.5; 3.8; 6.8 | 0.09 |
| SECONDARY Presence/Absence of Levodopa-induced Dyskinesia (LID). |
16; 8; 30 | 0.011 sig |
| SECONDARY Clinical Dyskinesia Rating Scale (Peak) |
1.9; 1.6; 3.6 | 0.033 sig |
Summary
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.
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)
Data sourced from ClinicalTrials.gov (NCT04064294). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.