Trial of Ursodeoxycholic Acid (UDCA) for PD. The 'UP-study'

Phase 1

• Conditions: Parkinson’s disease (PD); MedDRA version: 20.0 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2018-001887-46-GB
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-19
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Diagnosis of Parkinson’s disease = 3 years ago by a clinician with particular expertise in the diagnosis and treatment of movement disorders
• 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 the 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

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

? 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.
? 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-MRS
? Current or previous exposure to UDCA
? Current or previous diagnosis of liver disease, in particular PBC judged to be significant by the clinical investigator.
? 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 a score lower than 25 on the Montreal Cognitive assessment (MoCA). Dementia may affect the ability of potential research participants to give informed consent or follow the study protocol.
? Concurrent severe depression defined by a score > 16 on the Montgomery-Asberg Depression Rating Scale (MADRS)
? Serum transaminases more than 2 times upper
limit of normal
? PD patients who are on ciclosporin, nitrendipine or dapsone for the treatment of concomitant, general medical conditions

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified