PROSPECT
Research type
Research Study
Full title
A prospective observational study to evaluate the clinical outcomes and burden of disease of PD patients with motor fluctuations not adequately controlled by current PD medications.
IRAS ID
292756
Contact name
Donald G Grosset
Contact email
Sponsor organisation
AbbVie Ltd
Clinicaltrials.gov Identifier
EUPAS36303, EU PAS Register
Duration of Study in the UK
2 years, 6 months, 24 days
Research summary
Parkinson’s Disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. This study is an observational study to assess the clinical outcomes and burden of disease of PD participants with motor fluctuations not adequately controlled by current PD medications.
Data from a real-world setting in participants with PD will help to understand the disease burden and its evolution over time, and the impact of advanced therapies. Approximately 550 adult participants with a diagnosis of PD whose motor symptoms are inadequately controlled by oral medications will be enrolled. The study will be conducted in approximately 90 sites worldwide.
Participants will not receive any drugs administered as part of this study. Participants will be followed for 24 months. Each visit may be completed through virtual, home, or in-person office visit as decided by the investigator and per local regulations.Participants enrolled in this study may experience discomfort or inconvenience related to the study procedures. The impact will be assessed by measuring parameters like Off time (PD Diary), severity of disease, motor and non-motor symptoms, activities of daily living, quality of life, cognitive function, caregiver burden, and change in clinical outcomes, to name a few.
REC name
North of Scotland Research Ethics Committee 1
REC reference
21/NS/0037
Date of REC Opinion
27 Mar 2021
REC opinion
Favourable Opinion