NCT04381065Withdrawn
Utilization of Target Ranges to Treat Persons With Parkinson's Disease by Objective Measurement Using the PKG
Utilization of Target Ranges to Treat Persons With Parkinson's Disease by Objective Measurement Using the Personal KinetiGraph® (PKG®) Compared to Standard of Care Assessment (TARGET-PwP)- A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 1 Feb 2021
Reason given: Business decision
Brief summary (registry, in English)
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 quality of life when managed with the aid of objective measurement and use of PKG target ranges compared to PwP treated using only standard of care (SOC) (medical history, physical examination).
- Status (registry)
- Withdrawn
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 1 May 2020
- Start date
- Jun 2020
- Primary completion date
- Apr 2022
- Lead sponsor
- Global Kinetics Corporation
- Diseases
- Parkinson disease
- NCT number
- NCT04381065
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- Evidence of atypical or secondary parkinsonism
- Presence of any non-parkinsonian tremors
- Contraindication to increasing levodopa
- 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)
Who the study is looking for
- 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
Age in the registry: 55 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.