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

• Status: Recruiting
• Trial end date: 2021-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oregon Health and Science University
• Collaborator: Adamas Pharmaceuticals, Inc.
• Treatments: Amantadine

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