Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-31 @ 8:36 PM
Study NCT ID:
NCT03984305
Status:
TERMINATED
Last Update Posted:
2022-02-08
First Post:
2019-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Utilization of Target Ranges to Treat Parkinson's Disease With the PKG
Sponsor:
Global Kinetics Corporation
Organization:
Study Overview
Official Title:
Utilization of Target Ranges to Treat Patients With Parkinson's Disease by Objective Measurement Using the Personal KinetiGraph® (PKG®) Compared to Standard of Care Assessment (TARGET-PD)- A Randomized Controlled Trial
Status:
TERMINATED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to significant protocol updates that resulted in initiating a new study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TARGET-PD
Brief Summary:
The main objective of this study is to evaluate whether people whose PD symptoms are uncontrolled who are managed with the aid of objective measurement and use of target ranges have improved PD symptoms and outcomes as compared to individuals treated using only standard of care (medical history, neurological examination).
Detailed Description:
This is a randomized controlled trial (RCT) to evaluate treating uncontrolled patients with Parkinson's Disease (PwP) to a target range as suggested by expert review papers. The study aims to evaluate clinical patient outcomes, quality of life measures and health care utilization of those patients specifically treated to a target range when using the PKG data in the clinical management of Parkinson's disease (PD) in routine clinical care (treatment group) compared to those managed with medical history and clinical evaluation alone (control group) performed by a neurologist experienced in PD management. Both groups will be recommended to undergo medication changes until they reach a "controlled state" that is determined by either the clinician using standard of care (SOC) (PKG- Group) or using PKG based targets and SOC assessments (PKG+ Group).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: