Parkinson's disease Nervous System Diseases Parkinson's disease
Conditions
Interventions
Participants will be allocated at random in a 2:1 ratio to receive either ursodeoxycholic acid (UDCA) or a placebo.
Participants will start by just taking one capsule per day for the f
Gait Analysis
provision of a sensor (to gather data on how people walk and move in their natural home environment), blood tests and ECGs.
Visit 0: Screening (Time -1 – 8 prior to baseline visit)
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 11. Any medical or psychiatric condition which in the investigator’s opinion compromises the potential participant’s ability to participate 12. Concurrent dementia defined by a score lower than 25 on the Montreal Cognitive assessment (MoCA) 13. Concurrent severe depression defined by a score > 16 on the Montgomery-Asberg Depression Rating Scale (MADRS) 14. Serum transaminases more than 2 times upper limit of normal 15. Using ciclosporin, nitrendipine or dapsone for the treatment of concomitant, general medical conditions
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Assessed as a change from baseline to week 48: 1. Movement Disorders Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) part 3 motor subsection “OFF” medication score 2. In vivo parameter estimates of high and low energy metabolite levels (ATP, PCr, Pi), derived from cranial 31P-MRS centered on the basal ganglia and related motor regions 3. Objective quantification of motor impairment using motion sensors (Optogait and Opal sensor-based assessment: Sheffield patients only; Dynaport Movemonitor: all patients) | — |
Primary
| Measure | Time frame |
|---|---|
| The safety and tolerability of UDCA in Parkinson’s disease (PD) at a dose of 30 mg/kg, assessed by: 1. Number of serious adverse events (SAEs) 2. Number of adverse treatment reactions 3. Number of patients completing the study Assessed over the study period from start of treatment to week 56 | — |
Countries
England, United Kingdom
Outcome results
None listed