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

NCT ID: NCT04387773

Last Updated: 2024-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-05
• Study Completion Date: 2022-09-30

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GOCOVRI Treatment

All participants will have gait, balance, dyskinesia assessed before and after receiving GOCOVRI (274 mg/day).

Group Type: EXPERIMENTAL

GOCOVRI

Intervention Type: 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.

Interventions

GOCOVRI

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 Type: DRUG

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Adamas Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Amie Hiller, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amie Hiller, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20105

Identifier Type: -

Identifier Source: org_study_id