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Completed

NCT Number: NCT04387773

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)
  • ≥30 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

Treatment and study plan

GOCOVRI

Drug

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.

Primary outcomes

  1. Aim I: Investigate the Effect of GOCOVRI™ on Activity Levels in People With Parkinson's Disease (PD) and Levodopa Induced Dyskinesia (LID) Measure: Number of Walking Bouts Per Hour

    Time frame: Baseline and on drug; one week of daily life monitoring at each time point

    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 hypothesized that GOCOVRI™ would result in an increase of daily activity due to improvement in LID symptoms.

    Measure: number of walking bouts per hour

  2. Aim I: Investigate the Effect of GOCOVRI™ on Activity Levels in People With Parkinson's Disease (PD) and Levodopa Induced Dyskinesia (LID) Measure: Number of Turns Per Hour

    Time frame: Baseline and on drug; one week of daily life monitoring at each time point

    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 hypothesized that GOCOVRI™ would result in an increase of daily activity due to improvement in LID symptoms.

    Measure: number of turns per hour

  3. Aim I: Investigate the Effect of GOCOVRI™ on Activity Levels in People With Parkinson's Disease (PD) and Levodopa Induced Dyskinesia (LID) Measure: Total Number of Turns During the Day

    Time frame: Baseline and on drug; one week of daily life monitoring at each time point

    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 hypothesized that GOCOVRI™ would result in an increase of daily activity due to improvement in LID symptoms.

    Measure: total number of turns during the day

  4. Aim II: Investigate the Effect of GOCOVRI™ on Comprehensive Measures of Gait and Balance Quality in People With PD With LID Measure: Variability in the Turn Rate Per Step (CoV, Coefficient of Variation)

    Time frame: Baseline and on drug; one week of daily life monitoring at each time point

    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.

    Measure: Variability in the turn rate per step (CoV, Coefficient of Variation) Collection methods: wearable sensors worn during daily life used to measure participant walking characteristics; analysis extracts bouts of walking and turning, and specific gait measures for each are averaged across the weeklong collections; CoV calculated using standard deviation and mean of turn rate per step

  5. Aim II: Investigate the Effect of GOCOVRI™ on Comprehensive Measures of Gait and Balance Quality in People With PD With LID Measure: Variability in Total Number of Steps During Turns (CoV, Coefficient of Variation)

    Time frame: Baseline and on drug; one week of daily life monitoring at each time point

    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.

    Measure: variability in total number of steps during turns (CoV, Coefficient of Variation) Collection methods: wearable sensors worn during daily life used to measure participant walking characteristics; analysis extracts bouts of walking and turning, and specific gait measures for each are averaged across the weeklong collections; CoV calculated using standard deviation and mean of the number of steps to complete turns

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Adamas Pharmaceuticals, Inc.

Registry information

Official study title

Effect of GOCOVRI on Quantity and Quality of Gait in Parkinson's Disease

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 14, 2020
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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