CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 8 enrolled
Drug / intervention
GOCOVRIdrug
Likely dose
GOCOVRI 137mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04387773
NCT04387773Phase 4Completed
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Effect of GOCOVRI on Quantity and Quality of Gait in Parkinson's Disease

Oregon Health and Science University·interventional·Posted May 14, 2020·Updated Oct 10, 2024

In Brief

A Phase 4 clinical trial evaluating GOCOVRI for Parkinson Disease. Completed, enrolled 8 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson Disease
CountriesUnited States
CollaboratorsAdamas Pharmaceuticals, Inc.

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedMay 14, 2020
Enrollment StartNov 5, 2020
Primary CompletionSep 1, 2022
Study CompletionSep 30, 2022
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 6.1 years ago

Interventions

GOCOVRIdrug

Participants will have gait and balance baseline assessment and then repeat assessment after being on full-dose of GOCOVRI for two weeks. The assessments will include measures of gait, balance and dyskinesia. Participants will also wear body-worn sensors (on wrist, feet and lumbar area) during daily-life for seven days to quantify mobility. GOCOVRI will be started at 137mg/day for two weeks and then increased to 274mg/day for two weeks. Participants will repeat baseline assessments and then decrease to a dose of 137mg/day of GOCOVRI for one week, before stopping the medication completely. All participants will receive GOCOVRI and they will know that they are on study drug. No placebo group.