Status:
COMPLETED
Trial of Ursodeoxycholic Acid (UDCA) for Parkinson's Disease: The "UP" Study
Lead Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborating Sponsors:
JP Moulton Charitable Foundation
PRO.MED.CS Praha a.s.
Conditions:
Parkinson's Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The aim of this study is to explore the potential of Ursodeoxycholic acid (UDCA) to slow down the progression of Parkinson's Disease (PD) in a randomised, double-blind, placebo-controlled, "proof of c...
Detailed Description
The primary aim of this study is to generate clinical data to examine the safety, tolerability \& potential effectiveness of 48 weeks exposure to UDCA compared to placebo. Furthermore, it will determi...
Eligibility Criteria
Inclusion
- • Diagnosis of Parkinson's disease: PD is a clinical diagnosis as defined by the Queen Square Brain Bank criteria (bradykinesia defined as slowness of initiation of voluntary movement with progressive reduction in speed and amplitude on repetitive actions and at least one of the following: Rigidity, 4-6 Hz rest tremor). The diagnosis will have been made by the treating clinician and confirmed by the PI on site after review of the clinical history, examination findings and response to PD medication.
- The Queen Square brain bank criteria MAY be used to help assist in the diagnosis although this need not be a formal inclusion criteria, and the relevance of a positive family history of PD, or a confirmed genetic basis for an individual's symptoms will be evaluated in the context of other clinical features in determining diagnosis and eligibility.
- Diagnosis of Parkinson's disease ≤ 3 years ago by a clinician with particular expertise in the diagnosis and treatment of movement disorders (typically one of the PIs or their consultant colleagues). The date of diagnosis will be verified by a review of the medical records.
- Subjective improvement of motor impairment on dopaminergic medication, confirmed by PI through personal examination and/or review of medical records
- Hoehn and Yahr stage ≤ 2.5 in the practically defined "ON" medication state. This implies that all patients will be mobile without assistance during their best "ON" medication periods.
- Ability to take study drug
- Ability to communicate in English
- Age 18 - 75 yr of any gender
- Documented informed consent to participate
- Able to comply with study protocol and willing to attend necessary study visits
Exclusion
- Diagnosis or suspicion of other cause of parkinsonism such as Multiple system atrophy (MSA) or progressive supranuclear palsy (PSP), drug induced parkinsonism, dystonic tremor or essential tremor will not be recruited.
- Known abnormality on CT or MRI brain imaging considered likely to compromise compliance with trial/protocol/31P-MRS acquisition.
- Known claustrophobia or other reasons why patient could not tolerate or be suitable for 31P-MR Spectroscopy (31P-MRS)
- Current or previous exposure to UDCA
- Current or previous diagnosis of liver disease judged to be significant by the clinical investigator, in particular Primary Biliary Cholangitis (previously referred to as Primary Biliary Cirrhosis, PBC)
- Prior intracerebral surgical intervention for PD (including deep-brain stimulation). Patients who have previously undergone deep brain stimulation, intracerebral administration of growth factors, gene therapies or cell therapies will not be eligible.
- Already actively participating in a trial of a device, drug or surgical treatment for PD
- History of alcoholism
- Women of child - bearing potential (WOCBP)
- Participants who lack the capacity to give informed consent
- Any medical or psychiatric condition which in the investigator's opinion compromises the potential participant's ability to participate
- Concurrent dementia defined by Montreal Cognitive assessment (MoCA) score \<25
- Concurrent severe depression defined by a score \>16 on the Montgomery- Asberg Depression Rating Scale (MADRS)
- Serum transaminases (such as aspartate transaminase (AST) more than 2 times upper limit of normal.
- Patients on ciclosporin, nitrendipine or dapsone for the treatment of concomitant, general medical conditions.
- Participants with previous or current diagnosis of inflammatory bowel disease (i.e. ulcerative colitis or Crohn's disease)
Key Trial Info
Start Date :
December 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 13 2021
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03840005
Start Date
December 18 2018
End Date
May 13 2021
Last Update
November 8 2021
Active Locations (2)
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1
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, United Kingdom, S10 JJF
2
University College London Institute of Neurology
London, United Kingdom, WC1 3BG