Status:
WITHDRAWN
Utilization of Target Ranges to Treat Persons With Parkinson's Disease by Objective Measurement Using the PKG
Lead Sponsor:
Global Kinetics Corporation
Conditions:
Parkinson Disease
Eligibility:
All Genders
55-80 years
Phase:
NA
Brief Summary
The main objective of this study is to evaluate whether persons with Parkinson's disease (PwP) whose Parkinson's disease (PD) symptoms are uncontrolled have improved clinical patient outcomes and qual...
Detailed Description
This is a randomized controlled trial (RCT) to compare the value of the Personal KinetiGraph® (PKG®) System and SOC vs. the SOC alone for treatment of PwP. The study aims to evaluate clinical outcomes...
Eligibility Criteria
Inclusion
- Able and willing to sign a written informed consent for study participation and comply with all required follow-up visits
- Presumed to have levodopa responsive PD
- Taking levodopa for at least 30 days prior to screening visit
- Planning to continue using levodopa for PD throughout study participation
- Able to increase levodopa by a minimum of 100mg/day
- Age inclusive at the time of consent of 55-80 years
- Has not received a PKG in the last 12 months
Exclusion
- Evidence of atypical or secondary parkinsonism
- Presence of any non-parkinsonian tremors
- Contraindication to increasing levodopa
- Requires the addition of or dose adjustment of an anti-dyskinesia medication within the next 4 months
- Those who have received advanced therapies including individuals no longer actively utilizing these therapies, or planning to receive advanced therapies in the next 6 months
- MoCA score \<23 at screening visit
- Bedridden, wheelchair confined, or requires the regular use of an assistive gait device
- Predominant sleep period is during the daytime hours of 9am to 6pm (e.g. third shift worker)
- In the investigator's or sponsor's opinion, subject has any unstable or clinically significant condition that would impair the participant's ability to comply with study requirements or interfere with interpretation of the study endpoints
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04381065
Start Date
June 1 2020
End Date
April 1 2026
Last Update
February 1 2021
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