Actively Recruiting
Edmond J Safra Accelerating Clinical Trials in Parkinson's Disease: Multi-Arm Multi-Stage Platform Trial for Potential Disease Modifying Treatments
Led by University College, London · Updated on 2025-10-03
1200
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
Sponsors
U
University College, London
Lead Sponsor
C
Cure Parkinson's
Collaborating Sponsor
AI-Summary
What this Trial Is About
Parkinson's disease (PD) is a rapidly growing neurological condition that affects physical abilities and causes symptoms like difficulty with speech, swallowing, mood, thinking, and memory. Current treatments help with symptoms but lose effectiveness over time and may cause serious side effects. This trial uses a Multi-Arm, Multi-Stage (MAMS) design to test multiple treatments at once, comparing each to a placebo to assess safety and potential benefits. Promising treatments continue while ineffective ones are replaced, making the trial faster and more efficient. Participants will start in one of three groups: standard care plus placebo, standard care plus telmisartan, or standard care plus terazosin. The trial begins with two treatment arms and one placebo arm, with a third treatment arm added after one year. Treatments involve daily capsules with a 5-week titration phase to reach target doses, followed by up to 36 months of treatment. New treatments may be added yearly based on interim safety and effectiveness reviews. After an initial in-person screening, follow-up visits occur remotely at 3 months, 6 months, and every 6 months thereafter, up to 36 months. These visits include questionnaires, symptom assessments using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale, cognitive and mood tests, quality of life surveys, and safety monitoring. Participants will be kept informed of trial progress and results through the trial website and medical publications.
CONDITIONS
Brief Title
Edmond J. Safra Accelerating Clinical Trials in Parkinson's Disease: A Multiarm Multi-stage Platform Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with clinically established or probable Parkinson's disease by a neurologist or specialist
- Diagnosed with Parkinson's disease at age 30 years or older, no upper age limit
- Currently on Parkinson's medication (levodopa or dopamine agonists) for at least 2 months before screening
- Female participants of child-bearing potential must have a negative pregnancy test at screening
- Participants of child-bearing potential and their partners must use effective contraception
- Provided documented informed consent
- Eligible for at least one active treatment arm
- Randomisation within 4 weeks of the screening visit
- Additional timing requirements apply for participants being re-randomised
You will not qualify if you...
- Diagnosis or suspicion of other parkinsonism causes (atypical parkinsonism, essential tremor, drug-induced parkinsonism)
- Known carriers of recessive PD gene mutations PRKN, PINK1, or DJ1
- Clinical diagnosis of dementia or Montreal Cognitive Assessment (MoCA) score below 21 at screening
- Currently in another interventional trial or recent exposure to investigational medicinal products within 6 months
- Unable or unwilling to comply with study requirements
- Clinically significant depression or PHQ-9 score greater than 14 at screening
- Current suicidal ideation within one year before screening
- Previous or planned brain surgery including deep brain stimulation or advanced Parkinson's therapies
- Monotherapy with monoamine oxidase-B inhibitors
- Previous intolerance or recent exposure to study drugs
- Concurrent serious medical conditions or uncontrolled diseases that may affect participation
- Pregnant, breastfeeding, or planning pregnancy during the study or within 70 days after last dose
- Active cancer requiring treatment that may affect trial participation
- Liver disorders or abnormal liver function tests beyond specified limits
- History of alcohol or drug abuse within 3 years prior to screening
- Low blood pressure or orthostatic hypotension beyond specified thresholds
- Treatment-specific exclusions for telmisartan and terazosin including certain medications, allergies, or medical conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 weeks
Participants follow a 5-week dose titration phase to gradually reach the full dose of the study drug or placebo.
Weekly visits for 5 weeks
Duration - Up to 36 months
Participants take the assigned study drug or placebo once daily for up to 36 months in addition to their usual standard of care.
Regular scheduled visits approximately every 13 weeks throughout treatment
Duration - Up to 9 weeks after treatment end
Participants are monitored for safety and assessed at the end of the study or upon early termination.
1 final visit and possible early termination visits
Trial Site Locations
Total: 2 locations
1
UCLH
London, United Kingdom, NW1 2PG
Actively Recruiting
2
Clinical Ageing Research Unit
Newcastle, United Kingdom, NE4 5PL
Actively Recruiting
Research Team
M
MRC CTU at UCL Trial Team
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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