Effect of GOCOVRI (Amantadine, Extended Release Capsules) on Gait in Parkinson's Disease

NCT04387773 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 20105
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (5)

• 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

  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

  Baseline and on drug; one week of daily life monitoring at each time point

• 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

  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

  Baseline and on drug; one week of daily life monitoring at each time point

• 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

  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

  Baseline and on drug; one week of daily life monitoring at each time point

• 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)

  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

  Baseline and on drug; one week of daily life monitoring at each time point

• 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)

  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

  Baseline and on drug; one week of daily life monitoring at each time point

Study Arms (1)

GOCOVRI Treatment

EXPERIMENTAL

All participants will have gait, balance, dyskinesia assessed before and after receiving GOCOVRI (274 mg/day).

Drug: GOCOVRI

Interventions

GOCOVRI DRUG

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.

GOCOVRI Treatment

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Adamas Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Amantadine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Amie Hiller
• Organization: Oregon Health & Science University

peterami@ohsu.edu

503-494-7772

Study Officials

• Amie Hiller, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 14, 2020
• Study Start: November 5, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 30, 2022
• Last Updated: October 10, 2024
• Results First Posted: October 10, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 3 months to 5 years after study publication
• Access Criteria: Requesters will need to sign a data access agreement.

Locations

US (1)