CompletedPhase 4

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

United States8 participantsStarted 2020-11-05

Plain-language 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.

Who can participate

Age range50 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

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

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

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

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

Trial details

NCT IDNCT04387773

SponsorOregon Health and Science University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-01

Results submitted2024-07-26

View on ClinicalTrials.gov More Parkinson Disease trials

Who can participate

Age range50 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

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

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