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.
Full Title of Study: “Effect of GOCOVRI on Quantity and Quality of Gait in Parkinson’s Disease”
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: March 2021
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 number of steps and turns 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.
- Drug: GOCOVRI
- Participants will take have a baseline gait and balance visit followed by 7 days of home monitoring. Then, they will take 137mg/day of GOCOVRI for two weeks, before increasing the dosage to 274mg/day. After two weeks of the increased dose, participants will have 7 days of home monitoring, followed by a second gait and balance testing visit. Then, participants will take a decreased dose of 137mg/day of GOCOVRI for one week, before stopping the medication at the eighth week.
Arms, Groups and Cohorts
- Experimental: GOCOVRI Treatment
- Participants will receive GOCOVRI over a total of 7 weeks and do two gait and balance testing visits — one prior to starting GOCOVRI and one after 5 weeks of taking GOCOVRI. The first gait and balance visit is followed by 7 days of home monitoring with wearable sensors, and there are 7 days of home monitoring prior to the second gait and balance visit.
Clinical Trial Outcome Measures
- Total Number of Steps and Turns per Day
- Time Frame: 6 weeks
- Investigate the effect of GOCOVRI™ on activity levels in people with Parkinson’s disease (PD) and Levodopa induced dyskinesia (LID)
Participating in This Clinical Trial
- 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
- neurological or musculoskeletal disorders
- orthostatic hypotension at screening (defined as a drop of ≥20mm HG systolic and ≥10mm mercury (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
Gender Eligibility: All
Minimum Age: 50 Years
Maximum Age: 70 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Oregon Health and Science University
- Adamas Pharmaceuticals, Inc.
- Provider of Information About this Clinical Study
- Principal Investigator: Amie Hiller, MD, Associate Professor – Oregon Health and Science University
- Overall Official(s)
- Amie Hiller, MD, Principal Investigator, Oregon Health and Science University
- Overall Contact(s)
- Makena Strand, 503-418-2601, firstname.lastname@example.org
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