Clinical trial NCT04387773: Effect of GOCOVRI (Amantadine, Extended Release Capsules) on Gait in Parkinson's Disease
Official title: Effect of GOCOVRI on Quantity and Quality of Gait in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson Disease
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Adamas Pharmaceuticals, Inc.
First posted: 2020-05-14
Enrollment: 8
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline and on drug; one week of daily life monitoring at each time point
measure: 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
timeFrame: Baseline and on drug; one week of daily life monitoring at each time point
measure: 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
timeFrame: Baseline and on drug; one week of daily life monitoring at each time point
measure: 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)
timeFrame: Baseline and on drug; one week of daily life monitoring at each time point
measure: 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)
timeFrame: Baseline and on drug; one week of daily life monitoring at each time point
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Amie Hiller, MD
role: PRINCIPAL_INVESTIGATOR
References: