Status:
COMPLETED
Effect of GOCOVRI (Amantadine, Extended Release Capsules) on Gait in Parkinson's Disease
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
Adamas Pharmaceuticals, Inc.
Conditions:
Parkinson Disease
Eligibility:
All Genders
50-80 years
Phase:
PHASE4
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 l...
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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04387773
Start Date
November 5 2020
End Date
September 30 2022
Last Update
October 10 2024
Active Locations (1)
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1
Oregon Health & Science University
Portland, Oregon, United States, 97239