A phase II, placebo controlled, double blind, randomised clinical trial to assess the safety and tolerability of 30mg/kg daily ursodeoxycholic acid (UDCA) in patients with Parkinson’s disease

Overview

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32759251/ (added 27/04/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37246815/ (added 13/10/2023)

Registry

who.int

Start Date

November 26, 2018

End Date

November 1, 2020

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. Diagnosis of Parkinson’s disease \=3 years ago by a clinician with particular expertise in the diagnosis and treatment of movement disorders
•2\. Subjective improvement of motor impairment on dopaminergic medication, confirmed by PI through personal examination and/or review of medical records
•3\. 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.
•4\. Ability to take the study drug
•5\. Ability to communicate in English
•6\. Aged 18\-75 years
•7\. Documented informed consent to participate
•8\. Able to comply with study protocol and willing to attend necessary study visits

•1\. Diagnosis or suspicion of other cause of parkinsonism. Patients with clinical features indicating a diagnosis of progressive supranuclear palsy (PSP), multiple systems atrophy (MSA), drug induced\-parkinsonism, dystonic tremor or essential tremor will not be recruited.
•2\. Known abnormality on CT or MRI brain imaging considered likely to compromise compliance with trial protocol/31P\-MRS acquisition
•3\. Known claustrophobia or other reasons why patient could not tolerate or be suitable for 31P\-MRS
•4\. Current or previous exposure to UDCA
•5\. Current or previous diagnosis of liver disease, in particular PBC judged to be significant by the clinical investigator
•6\. 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.
•7\. Already actively participating in a trial of a device, drug or surgical treatment for PD
•8\. History of alcoholism
•9\. Women of child\-bearing potential (WOCBP)
•10\. Participants who lack the capacity to give informed consent