Effect of GOCOVRI (Amantadine, Extended Release Capsules) on Gait in Parkinson's Disease
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.
Timeline
- Start
- 2020-11-05
- Primary completion
- 2022-09-01
- Completion
- 2022-09-30
Outcome
Mixed primary results
registry analysis (superiority test); GOCOVRI Treatment; p >.05; Mean Difference (Final Values) 2.3; t-test, 2 sided NCT04387773 ↗
registry analysis (superiority test); GOCOVRI Treatment; p >.05; Mean Difference (Final Values) 14.98; t-test, 2 sided NCT04387773 ↗
registry MEAN GOCOVRI Treatment: Baseline: 6540.7 (Standard Deviation 3024.5) Total number of turns per day NCT04387773 ↗
registry MEAN GOCOVRI Treatment: On drug: 4147.5 (Standard Deviation 2188.9) Total number of turns per day NCT04387773 ↗
registry analysis (superiority test); GOCOVRI Treatment; p = 0.037; Mean Difference (Final Values) 2393.2; t-test, 2 sided NCT04387773 ↗
registry analysis (superiority test); GOCOVRI Treatment; p = 0.047; Mean Difference (Final Values) 0.02; t-test, 2 sided NCT04387773 ↗
registry MEDIAN GOCOVRI Treatment: Baseline: 0.55 (0.50 to 0.67) CoV, unitless (mean divided by Standard) NCT04387773 ↗
registry MEDIAN GOCOVRI Treatment: On drug: 0.53 (0.48 to 0.63) CoV, unitless (mean divided by Standard) NCT04387773 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amantadine | Unknown | 274 mg | — |