Effect of GOCOVRI (Amantadine Extended Release Capsules) on Gait in Parkinson's Disease

  • STATUS
    Recruiting
  • days left to enroll
    8
  • participants needed
    12
  • sponsor
    Oregon Health and Science University
Updated on 29 April 2021

Summary

The purpose of the study is to learn about the effect of GOCOVRI (Amantadine extended release) on activity levels and measures of gait and balance quality in people with Parkinson's disease (PD) and levodopa induced dyskinesia (LID) during daily activities using body-worn sensors.

Description

Levodopa induced dyskinesia (LID) is a symptom of Parkinson's disease for which there are limited treatment options. LID leads to reduced quality of life, increased caregiver burden and an increased risk of falls (Rascol et al., 2015, Chapuis et al., 2005). GOCOVRI is an extended release capsule prescription medication shown to reduce LID in people with PD (Pahwa et al., 2017, Pahwa et al., 2018). However, a number of studies have identified an increase in falls in those on the active medication study arm but not the placebo arm (13% increase in active and 7% in placebo) (Pahwa et al., 2017). In order to understand this increase in falls, comprehensive measurements of quantity of activity (gait measured in the home environment) and quality of activity (comprehensive gait characteristics that may increase risk of falls) need to be assessed in participants taking GOCOVRI. In addition, the evidence for the effect of GOCOVRI on gait and balance in PD is limited (Smulders et al., 2016).

This study is an open label study in which the following Aims will be studied:

Aim I: Investigate the effect of GOCOVRI on activity levels in people with Parkinson's disease (PD) and Levodopa induced dyskinesia (LID) Hypothesis I: We hypothesize that GOCOVRI will result in an increase of daily activity due to improvement in LID symptoms. Primary outcome measures: Total amount of activity per day

Aim II: Investigate the effect of GOCOVRI on comprehensive measures of gait and balance quality in people with PD with LID Hypothesis II: We hypothesize GOCOVRI may improve discrete characteristics of gait and balance that is evident even within the first hour of the day walking.

Details
Condition Parkinson's disease, parkinson's, parkinson disease
Treatment GOCOVRI
Clinical Study IdentifierNCT04387773
SponsorOregon Health and Science University
Last Modified on29 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Idiopathic Parkinson'd Disease in accordance with the United Kingdom (UK) Brain Bank Criteria
Hoehn & Yahr scores of II-IV
subjective report of experiencing at least 1hr/day (two, half-hour periods) of ON time with troublesome Levodopa-Induced Dyskinesia (LID)
ambulation with or without aids (e.g., walker or cane)
days of a stable regimen of anti-Parkinson's medications that includes a levodopa dose administered 3 times daily
a stable dose of levodopa throughout the study
no amantadine for a minimum of 30 days prior to enrollment in the study

Exclusion Criteria

neurological or musculoskeletal disorders
orthostatic hypotension at screening (defined as a drop of 20mm mercury (HG) systolic and 10mm HG diastolic at 2 or 5 minutes of quiet standing after 5 minutes of supine rest)
a major psychotic disorder
contraindication to GOCOVRI at time of screening, especially renal impairment estimated by glomerular filtration rate (eGFR) < 50 ml/min/1.73 m2) as impaired renal function can increase the chances of adverse reactions to the study drug
mild to severe cognitive impairment as measured by Montreal Cognitive Assessment (MoCA) score 23
concurrent use of immediate release amantadine
are pregnant or plan to become pregnant
an implanted deep brain stimulator
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

0/250
Preferred Language
Other Language
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...

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