- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04387773
Effect of GOCOVRI (Amantadine, Extended Release Capsules) on Gait in Parkinson's Disease
Effect of GOCOVRI on Quantity and Quality of Gait in Parkinson's Disease
Study Overview
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 risk of falls (Rascol et al., 2015, Chapuis et al., 2005). GOCOVRI™ is an extended release capsule prescription medication shown to reduce LID in people with PD (Pahwa et al., 2017, Pahwa et al., 2018). However, a number of studies have identified an increase in falls in those on the active medication study arm but not the placebo arm (13% increase in active and 7% in placebo) (Pahwa et al., 2017). In order to understand this increase in falls, comprehensive measurements of quantity of activity (gait measured in the home environment) and quality of activity (comprehensive gait characteristics that may increase risk of falls) need to be assessed in participants taking GOCOVRI™. In addition, the evidence for the effect of GOCOVRI™ on gait and balance in PD is limited (Smulders et al., 2016).
This study is an open label study in which the following Aims will be studied:
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 hypothesize that GOCOVRI™ will result in an increase of daily activity due to improvement in LID symptoms. Primary outcome measures: Total amount of activity per day
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Graham Harker
- Phone Number: 503-418-2601
- Email: harkerg@ohsu.edu
Study Contact Backup
- Name: Austin Prewitt
- Phone Number: 5034182602
- Email: prewitta@ohsu.edu
Study Locations
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Oregon
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Portland, Oregon, United States, 97239
- Recruiting
- Oregon Health & Science University
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Contact:
- Graham Harker
- Phone Number: 503-418-2601
- Email: harkerg@ohsu.edu
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Principal Investigator:
- Amie Hiller, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GOCOVRI Treatment
All participants will have gait, balance, dyskinesia assessed before and after receiving GOCOVRI (274 mg/day).
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Total amount of activity per day
Time Frame: 6 weeks
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Investigate the effect of GOCOVRI™ on activity levels in people with Parkinson's disease (PD) and Levodopa induced dyskinesia (LID).
Body-worn sensors will be used to quantify the amount of activity each day over a week.
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6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Total Activity during first waking hour
Time Frame: 6 weeks
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Using body-worn sensors will quantify the amount of activity during the first awake hour of each day over a week.
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6 weeks
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Change in stride duration variability
Time Frame: 6 weeks
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Body-worn sensors will be used to quantify stride duration variability during gait in daily life.
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6 weeks
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Change turning speed
Time Frame: 6 weeks
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Body-worn sensors will be used to identify turns and quantify turning speed during daily life.
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6 weeks
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Change in Parkinson's Disease Questionnaire 39 Score
Time Frame: 6 weeks
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The Parkinson's Disease Quality of Life questionnaire with 39 questions (PDQ-39) reflects eight domains of quality of life (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort).
Each item scores from 0 (never) to 4 (always).
Sub-scale scores and a Parkinson's Disease summary index (PDSI; sum of eight subsections/8) representing the global health-related quality of life will be calculated, with higher scores representing worse quality of life.
Convergent validity is very good and discriminative validity for PD severity levels has been established.
The PDQ-39 will be a Patient Reported Outcome to reflect limitations to participation in community mobility.
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6 weeks
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Change in International Physical Activity Questionnaire
Time Frame: 6 weeks
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This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in metabolic expenditure (MET) minutes a week and time spent sitting.
Subjects score as low, moderate, or high levels of activity categories.
It will be used as a second Patient Reported Outcome to reflect the level of activity during the day.
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6 weeks
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Change in Movement Disorders Society - Unified Dyskinesia Rating Scale
Time Frame: 6 weeks
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This will be one of two assessments for Levodopa Induce Dyskinesias (LID).
This scale evaluates the involuntary movements often associated with treated Parkinson's disease.
There are two primary sections: Historical [Part 1 (On-Dyskinesia) and Part 2 (Off-Dystonia)] and Objective [Part 3 (Impairment) and Part 4 (Disability)].
Score ranges are 0 to 44 for Part I, 0 to 16for Part II, 0 to 28 for Part III, and 0 to 16 for Part IV,with a total score range of 0 to 104.
Higher scores reflect more severe dyskinesia.
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6 weeks
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Change in modified Abnormal Involuntary Movement Scale
Time Frame: 6 weeks
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The Abnormal Involuntary Movement Scale (AIMS) is an assessment of the occurrence of tardive dyskinesia The AIMS test has a total of twelve items rating involuntary movements of various areas of the patient's body.
These items are rated on a five-point scale of severity from 0-4.
The scale is rated from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe).
Total score ranges from 0 to 48 with higher scores reflecting more severe dyskinesia.
We will compare total scores.
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6 weeks
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Amie Hiller, MD, Oregon Health and Science University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20105 (Other Grant/Funding Number: Arthritis Research UK)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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