Involving people with Parkinson's in clinical endpoint design
Research type
Research Study
Full title
Survey on relevant symptoms for people with Parkinson's disease to design novel milestone-based outcome measures
IRAS ID
342155
Contact name
Cristina Gonzalez-Robles
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2024/05/246 clinical research, Data Protection Reference Number
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Parkinson's disease (PD) is the fastest-growing, neurodegenerative condition in the world. In PD, a lack of a chemical called dopamine in the brain causes progressive problems, both of movement (slowness, tremor, stiffness) and of other functions (thinking, mood, bowel, bladder).
There are currently no treatments to slow or stop this condition, and this may be in part due to the fact that symptomatic treatments interfere with clinician assessments (i.e. the condition varies within and between days depending on the medications), so better ways of measuring disease progression are needed. Furthermore, input from people with Parkinson's (PwP) is crucial to ensure that the issues relevant to them are being addressed in future studies assessing promising treatments.
This study will survey PwP followed up in Queen Square clinics about the relevance of each of a list of symptoms/issues which constitute potential milestones of disease progression in PD. This information will then be used to understand their priorities and to analyse large datasets to look into milestone-related measures which include the issues flagged as most relevant by them. We aim to recruit a representative sample of between 200 and 500 participants. Potential participants will either be approached at their routine clinic appointments or contacted directly (if they gave previous consent to be contacted to participate in research).
The ultimate aim is to design a milestone-related measure that encompasses those issues which are most relevant to PwP. This measure will then be potentially implemented as part of future clinical trials of PD treatments which aim to slow/stop its progression.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
24/EM/0177
Date of REC Opinion
16 Sep 2024
REC opinion
Further Information Favourable Opinion