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Preventing Levodopa Induced Dyskinesia in Parkinson's Disease With HMG-CoA Reductase Inhibitors (STAT-PD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04064294
Recruitment Status : Active, not recruiting
First Posted : August 21, 2019
Last Update Posted : April 20, 2020
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment
Parkinson Disease Dyskinesia, Drug-Induced Drug: Intravenous Infusion

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.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Preventing Levodopa Induced Dyskinesia in Parkinson?s Disease With Statins
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : March 31, 2023


Group/Cohort Intervention/treatment
Statin Before Levodopa
Historical use of a statin (simvastatin or lovastatin) BEFORE beginning levodopa
Drug: Intravenous Infusion
Intravenous levodopa given 1.0 to 1.5 mg/kg/hr from 0930 - 1130 on a single visit day.
Other Name: levodopa

Statin After Levodopa
Historical use of a statin (simvastatin or lovastatin) AFTER beginning levodopa
Drug: Intravenous Infusion
Intravenous levodopa given 1.0 to 1.5 mg/kg/hr from 0930 - 1130 on a single visit day.
Other Name: levodopa

No Statin
No historical use of a statin (simvastatin or lovastatin)
Drug: Intravenous Infusion
Intravenous levodopa given 1.0 to 1.5 mg/kg/hr from 0930 - 1130 on a single visit day.
Other Name: levodopa




Primary Outcome Measures :
  1. Peak Unified Dyskinesia Rating Score (UDysRS) [ Time Frame: 11:00 am ]
    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.


Secondary Outcome Measures :
  1. phosphorylated ERK1/2 Levels in CD3/CD20 lymphocytes [ Time Frame: 11:15 am ]
    Immunodetection of pERK with antibody against the phosphorylated forms of Tyrosine202 and 204 of ERK1/2 (AlexaFluor488 BD Biosciences) will occur in lymphocytes isolated from whole blood using flow cytometry.


Biospecimen Retention:   Samples With DNA
plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Parkinson's Disease
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 ie atorvastatin, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064294


Locations
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United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239not
VA Portland Health Care System, Portland, OR
Portland, Oregon, United States, 97239
United States, Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108
Sponsors and Collaborators
VA Office of Research and Development
Oregon Health and Science University
Investigators
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Principal Investigator: Kathryn Anne Chung, MD VA Portland Health Care System, Portland, OR
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:
Informed Consent Form  [PDF] November 14, 2018

Publications:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04064294    
Other Study ID Numbers: NURE-004-18S
17302 ( Other Grant/Funding Number: Oregon Health and Science University )
3869 ( Other Identifier: VA Portland Health Care System )
5273 ( Other Identifier: Oregon Clinical & Translational Research Institute )
First Posted: August 21, 2019    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Informed Consent Form (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.
URL: http://www.parkinsons.va.gov/northwest/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Parkinson Disease
Dyskinesias
Dyskinesia, Drug-Induced
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
Neurotoxicity Syndromes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Poisoning
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs