Trial Outcomes & Findings for Effect of GOCOVRI (Amantadine, Extended Release Capsules) on Gait in Parkinson's Disease (NCT NCT04387773)
NCT ID: NCT04387773
Last Updated: 2024-10-10
Results Overview
Aim I: Investigate the effect of GOCOVRI™ on activity levels in people with Parkinson's disease (PD) and Levodopa induced dyskinesia (LID). Hypothesis I: We hypothesized that GOCOVRI™ would result in an increase of daily activity due to improvement in LID symptoms. Measure: number of walking bouts per hour
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
8 participants
Primary outcome timeframe
Baseline and on drug; one week of daily life monitoring at each time point
Results posted on
2024-10-10
Participant Flow
Participant milestones
| Measure |
GOCOVRI Treatment
All participants will have gait, balance, dyskinesia assessed before and after receiving GOCOVRI (274 mg/day).
GOCOVRI: 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.
|
|---|---|
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Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of GOCOVRI (Amantadine, Extended Release Capsules) on Gait in Parkinson's Disease
Baseline characteristics by cohort
| Measure |
GOCOVRI Treatment
n=8 Participants
All participants will have gait, balance, dyskinesia assessed before and after receiving GOCOVRI (274 mg/day).
GOCOVRI: 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.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
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1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
70.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
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Years since Parkinson's disease diagnosis
|
9.25 years
n=5 Participants
|
|
Years with levodopa induced dyskinesias
|
3 years
n=5 Participants
|
|
Participants with one or more falls in the last 12-months
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and on drug; one week of daily life monitoring at each time pointPopulation: 1 participant that completed the protocol was not included for analysis due to incomplete data
Aim I: Investigate the effect of GOCOVRI™ on activity levels in people with Parkinson's disease (PD) and Levodopa induced dyskinesia (LID). Hypothesis I: We hypothesized that GOCOVRI™ would result in an increase of daily activity due to improvement in LID symptoms. Measure: number of walking bouts per hour
Outcome measures
| Measure |
GOCOVRI Treatment
n=4 Participants
All participants will have gait, balance, dyskinesia assessed before and after receiving GOCOVRI (274 mg/day).
GOCOVRI: 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.
|
|---|---|
|
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
Baseline
|
9.98 Average number of walking bouts per hour
Standard Deviation 6.23
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|
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
On drug
|
7.68 Average number of walking bouts per hour
Standard Deviation 4.86
|
PRIMARY outcome
Timeframe: Baseline and on drug; one week of daily life monitoring at each time pointPopulation: 1 participant that completed the protocol was not included for analysis due to incomplete data
Aim I: Investigate the effect of GOCOVRI™ on activity levels in people with Parkinson's disease (PD) and Levodopa induced dyskinesia (LID). Hypothesis I: We hypothesized that GOCOVRI™ would result in an increase of daily activity due to improvement in LID symptoms. Measure: number of turns per hour
Outcome measures
| Measure |
GOCOVRI Treatment
n=4 Participants
All participants will have gait, balance, dyskinesia assessed before and after receiving GOCOVRI (274 mg/day).
GOCOVRI: 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.
|
|---|---|
|
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
Baseline
|
84.78 Average number of turns per hour
Standard Deviation 18.47
|
|
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
On drug
|
69.8 Average number of turns per hour
Standard Deviation 31.92
|
PRIMARY outcome
Timeframe: Baseline and on drug; one week of daily life monitoring at each time pointPopulation: 1 participant that completed the protocol was not included for analysis due to incomplete data
Aim I: Investigate the effect of GOCOVRI™ on activity levels in people with Parkinson's disease (PD) and Levodopa induced dyskinesia (LID). Hypothesis I: We hypothesized that GOCOVRI™ would result in an increase of daily activity due to improvement in LID symptoms. Measure: total number of turns during the day
Outcome measures
| Measure |
GOCOVRI Treatment
n=4 Participants
All participants will have gait, balance, dyskinesia assessed before and after receiving GOCOVRI (274 mg/day).
GOCOVRI: 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.
|
|---|---|
|
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
Baseline
|
6540.7 Total number of turns per day
Standard Deviation 3024.5
|
|
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
On drug
|
4147.5 Total number of turns per day
Standard Deviation 2188.9
|
PRIMARY outcome
Timeframe: Baseline and on drug; one week of daily life monitoring at each time pointPopulation: 1 participant that completed the protocol was not included for analysis due to incomplete data
Aim II: Investigate the effect of GOCOVRI™ on comprehensive measures of gait and balance quality in people with PD with LID Hypothesis II: We hypothesize GOCOVRI™ may improve discrete characteristics of gait and balance that is evident even within the first hour of the day walking. Measure: Variability in the turn rate per step (CoV, Coefficient of Variation) Collection methods: wearable sensors worn during daily life used to measure participant walking characteristics; analysis extracts bouts of walking and turning, and specific gait measures for each are averaged across the weeklong collections; CoV calculated using standard deviation and mean of turn rate per step
Outcome measures
| Measure |
GOCOVRI Treatment
n=4 Participants
All participants will have gait, balance, dyskinesia assessed before and after receiving GOCOVRI (274 mg/day).
GOCOVRI: 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.
|
|---|---|
|
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)
Baseline
|
0.39 CoV, unitless (mean divided by Standard)
Interval 0.37 to 0.43
|
|
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)
On drug
|
0.42 CoV, unitless (mean divided by Standard)
Interval 0.38 to 0.45
|
PRIMARY outcome
Timeframe: Baseline and on drug; one week of daily life monitoring at each time pointPopulation: 1 participant that completed the protocol was not included for analysis due to incomplete data
Aim II: Investigate the effect of GOCOVRI™ on comprehensive measures of gait and balance quality in people with PD with LID Hypothesis II: We hypothesize GOCOVRI™ may improve discrete characteristics of gait and balance that is evident even within the first hour of the day walking. Measure: variability in total number of steps during turns (CoV, Coefficient of Variation) Collection methods: wearable sensors worn during daily life used to measure participant walking characteristics; analysis extracts bouts of walking and turning, and specific gait measures for each are averaged across the weeklong collections; CoV calculated using standard deviation and mean of the number of steps to complete turns
Outcome measures
| Measure |
GOCOVRI Treatment
n=4 Participants
All participants will have gait, balance, dyskinesia assessed before and after receiving GOCOVRI (274 mg/day).
GOCOVRI: 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.
|
|---|---|
|
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)
Baseline
|
0.55 CoV, unitless (mean divided by Standard)
Interval 0.5 to 0.67
|
|
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)
On drug
|
0.53 CoV, unitless (mean divided by Standard)
Interval 0.48 to 0.63
|
Adverse Events
GOCOVRI Half Dose (Week 0-2)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
GOCOVRI Full Dose (Week 2-4)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
GOCOVRI Half Dose (Week 4-5)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
GOCOVRI Half Dose (Week 0-2)
n=8 participants at risk
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 (half dose) and, if tolerated, increased to 274mg/day for two weeks (full dose). Participants will repeat assessments and then decrease to a dose of 137mg/day (half dose) 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.
|
GOCOVRI Full Dose (Week 2-4)
n=6 participants at risk
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 (half dose) and, if tolerated, increased to 274mg/day for two weeks (full dose). Participants will repeat assessments and then decrease to a dose of 137mg/day (half dose) 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.
|
GOCOVRI Half Dose (Week 4-5)
n=5 participants at risk
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 (half dose) and, if tolerated, increased to 274mg/day for two weeks (full dose). Participants will repeat assessments and then decrease to a dose of 137mg/day (half dose) 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.
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|---|---|---|---|
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General disorders
Dry mouth (xerostomia)
|
12.5%
1/8 • Number of events 1 • Adverse events were followed for the 6-weeks of study participation.
Definitions did not differ
|
0.00%
0/6 • Adverse events were followed for the 6-weeks of study participation.
Definitions did not differ
|
0.00%
0/5 • Adverse events were followed for the 6-weeks of study participation.
Definitions did not differ
|
|
Vascular disorders
Orthostatic hypotension
|
12.5%
1/8 • Number of events 1 • Adverse events were followed for the 6-weeks of study participation.
Definitions did not differ
|
0.00%
0/6 • Adverse events were followed for the 6-weeks of study participation.
Definitions did not differ
|
0.00%
0/5 • Adverse events were followed for the 6-weeks of study participation.
Definitions did not differ
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/8 • Adverse events were followed for the 6-weeks of study participation.
Definitions did not differ
|
16.7%
1/6 • Number of events 1 • Adverse events were followed for the 6-weeks of study participation.
Definitions did not differ
|
0.00%
0/5 • Adverse events were followed for the 6-weeks of study participation.
Definitions did not differ
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place