Preventing Levodopa Induced Dyskinesia in Parkinson's Disease With HMG-CoA Reductase Inhibitors

NCT04064294 | Completed Results DMC FDA Drug

• 5 other identifiers: NURE-004-18S17302386952731635227
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Parkinson Disease; Dyskinesia, Drug-Induced

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

Study Arms (3)

Statin Before Levodopa

Historical use of a statin BEFORE beginning levodopa

Drug: Intravenous Infusion

Statin After Levodopa

Historical use of a statin AFTER beginning levodopa

Drug: Intravenous Infusion

No Statin

No historical use of a statin

Drug: Intravenous Infusion

Interventions

Intravenous Infusion DRUG

Intravenous levodopa given 1.0 to 1.5 mg/kg/hr from 0930 - 1130 on a single visit day.

Also known as: levodopa

No Statin; Statin After Levodopa; Statin Before Levodopa

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Parkinson's Disease

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Oregon Health and Science University: collaborator

Study Sites (3)

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97207-2964, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239not, United States

Location

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108, United States

Location

Related Publications (3)

• 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.

  PMID: 10762129 BACKGROUND

• 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.

  PMID: 23283428 BACKGROUND

• 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.

  PMID: 16139809 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

plasma

MeSH Terms

Conditions

Parkinson Disease; Dyskinesia, Drug-Induced

Interventions

Infusions, Intravenous; Levodopa

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Neurotoxicity Syndromes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Poisoning

Intervention Hierarchy (Ancestors)

Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Infusions, Parenteral; Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Kathryn Chung
• Organization: Portland VA Health Care System

Kathryn.Chung@va.gov

(503) 721 -1091

Study Officials

• Kathryn Anne Chung, MD

  VA Portland Health Care System, Portland, OR

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 21, 2019
• Study Start: August 22, 2019
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: April 11, 2025
• Results First Posted: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: beginning 5 months and ending 2 years following article publication.
• Access Criteria: 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.

Locations

US (3)