Effect of GOCOVRI (Amantadine, Extended Release Capsules) on Gait in Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 4

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.
    

Detailed 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.
    

Intervention name(s): GOCOVRI
Intervention type(s): Drug
Intervention description(s): Participants will have gait and balance baseline assessment and then repeat assessment after being on full-dose of GOCOVRI for two weeks. The assessments will include measures of gait, balance and dyskinesia. Participants will also wear body-worn sensors (on wrist, feet and lumbar area) during daily-life for seven days to quantify mobility.
GOCOVRI will be started at 137mg/day for two weeks and then increased to 274mg/day for two weeks. Participants will repeat baseline assessments and then decrease to a dose of 137mg/day of GOCOVRI for one week, before stopping the medication completely.
All participants will receive GOCOVRI and they will know that they are on study drug. No placebo group.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment