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

  • STATUS
    Recruiting
  • End date
    Mar 31, 2024
  • participants needed
    120
  • sponsor
    VA Office of Research and Development
Updated on 1 March 2021
levodopa
dyskinesia

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.

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.

Details
Condition Drug-induced dyskinesia, Parkinson's disease, parkinson's, parkinson disease
Treatment Intravenous Infusion
Clinical Study IdentifierNCT04064294
SponsorVA Office of Research and Development
Last Modified on1 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 50 yrs?
Gender: Male or Female
Do you have any of these conditions: Parkinson's disease or Drug-induced dyskinesia?
Do you have any of these conditions: Drug-induced dyskinesia or parkinson's or Parkinson's disease or parkinson disease?
Do you have any of these conditions: Parkinson's disease or Drug-induced dyskinesia or parkinson disease or parkinson's?
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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note