Phase 4
N=8
Effect of GOCOVRI (Amantadine, Extended Release Capsules) on Gait in Parkinson's Disease
Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT04387773 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: 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 — 9.98; 7.68 Average number of walking bouts per hour — p=>.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- GOCOVRI (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Oregon Health and Science University
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
9.98; 7.68 | >.05 |
| PRIMARY 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 |
84.78; 69.8 | >.05 |
| PRIMARY 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 |
6540.7; 4147.5 | 0.037 sig |
| PRIMARY 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) |
0.39; 0.42 | 0.012 sig |
| PRIMARY 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) |
0.55; 0.53 | 0.047 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT04387773). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.