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Parkinson DiseaseSTAT-PDNCT04064294

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

An observational study of Parkinson Disease and Dyskinesia, Drug-Induced, run by VA Office of Research and Development at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Parkinson Disease, Dyskinesia, Drug-Induced
What is being tested?
Intravenous Infusion
Type of treatment
Injection or infusion
How many people
93 participants
Where
3 sitesUnited States
Study dates
22 Aug 2019to 31 Mar 2024
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Parkinson's Disease

Who may be able to join

  • 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

Who cannot join

  • 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:
Show all 17Show fewer
  • 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)

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • VA Portland Health Care System, Portland, OR

    Portland, Oregon, 97207-2964

  • Oregon Health & Science University

    Portland, Oregon, 97239not

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

    Seattle, Washington, 98108

Other trials in United States

About this study

Official title: Preventing Levodopa Induced Dyskinesia in Parkinson's Disease With Statins

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.

Read the detailed description

Long term treatment with levodopa, the gold standard treatment of Parkinson's disease (PD), can lead to the development of abnormal involuntary movements called levodopa induced dyskinesia (LID). The severity of LID can range from mild to severely debilitating. A majority of PD patients will develop LID in their treatment life-time. In a recent study of the MPTP monkey model of PD, statin use was found to reduce LID (45%) without a worsening of Parkinsonism symptoms1. Another study showed rats treated with lovastatin prior to and with initiation of levodopa after substantia nigra lesioning showed dramatically less LID evolution compared to animals without lovastatin exposure2. 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. This study is a retrospective three cohort design and will compare statin exposure BEFORE beginning LD, versus statin exposure AFTER LD is begun, versus NO statin exposure in PD subjects controlling for disease characteristics (severity), gender, and total LD exposure The primary endpoint is the severity of LID between the groups after years of opportunity to develop LID. Levodopa-Induced dyskinesia is a major cause of reduced quality of life for Veterans with PD and, in some cases, leads to costly surgical interventions. This project examines the impact of statin use on the presence of LID, and could lead to a future intervention trial. The reduction, delayed onset, or elimination of LID could improve the quality of life of many Veterans nationwide.

Being tested
Intravenous Infusion
Medical subject headings
Parkinson Disease, Dyskinesia, Drug-Induced

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intravenous InfusionDrug

    Also called levodopa

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

Study groups in NCT04064294
Study groupRoleWhat they receive
Statin Before LevodopaHistorical use of a statin BEFORE beginning levodopa
Receives: Drug: Intravenous Infusion
Statin After LevodopaHistorical use of a statin AFTER beginning levodopa
Receives: Drug: Intravenous Infusion
No StatinNo historical use of a statin
Receives: Drug: Intravenous Infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 11:00 am

Secondary outcomes (3)

  1. Peak Unified Dyskinesia Rating Scale - Objective Measures

    The Unified Dyskinesia Rating Scale (UDysRS) objective (Part 3 \& 4) assessments of dyskinesia and dystonia. The objective ratings are added together to form total score ranging from 0 to 44 with higher scores indicating more severe dyskinesia.

    Measured: 11:00 am

  2. Presence/Absence of Levodopa-induced Dyskinesia (LID).

    Any score greater than or equal to 1 on the Clinical Dyskinesia Rating Scale (CDRS) during the intravenous levodopa cycle from 0900 - 1500. The CDRS is a commonly utilized scale that is completed by an observer who judges the severity of LID (0-4) in 7 body parts (face, neck, trunk, both legs, and both arms) during as the subject performs the cognitive distraction task while standing on the force plate for 60 seconds. CDRS ratings are made every half hour during the LD dose cycle by the principal investigator (KC) or co-investigator.

    Measured: Every half hour from 0900 to 1500

  3. Clinical Dyskinesia Rating Scale (Peak)

    The Clinical Dyskinesia Rating Scale (CDRS) is a commonly utilized scale that is completed by an observer who judges the severity of Levodopa induced dyskinesia (LID) in 7 body parts (face, neck, trunk, both legs, and both arms) during the force plate stance with a cognitive distraction task for 60 seconds. All body parts are rated separately on this 0 (none) to 4 (severe - markedly impairs activities) scale. Thus, the total score can range from 0 - 28 with 28 indicating the most severe LID. Peak CDRS ratings are the 11:00 am ratings.

    Measured: 11:00 am

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2019
  2. Study start22 Aug 2019
  3. Primary completion31 Mar 2024
  4. Study completion31 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04064294
Sponsor's protocol ID
NURE-004-18S
Other IDs
17302, 3869, 5273, 1635227
Acronym
STAT-PD
Status last verified
Apr 2025
First submitted
19 Aug 2019
Last updated
11 Apr 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 10762129

  • 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.

    PubMed 23283428

  • 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.

    PubMed 16139809

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson Disease and Dyskinesia, Drug-Induced, run by VA Office of Research and Development at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak Unified Dyskinesia Rating Score (UDysRS) (time frame: 11:00 am). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04064294, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.

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