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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03840005
Date of registration: 11/02/2019
Prospective Registration: No
Primary sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Public title: Trial of Ursodeoxycholic Acid (UDCA) for Parkinson's Disease: The "UP" Study
Scientific title: 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 (PD)
Date of first enrolment: December 18, 2018
Target sample size: 30
Recruitment status: Active, not recruiting
URL:  https://clinicaltrials.gov/show/NCT03840005
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Triple (Participant, Investigator, Outcomes Assessor).  
Phase:  Phase 2
Countries of recruitment
United Kingdom
Contacts
Name:     Oliver Bandmann
Address: 
Telephone:
Email:
Affiliation:  Sheffield Teaching Hospitals NHS Foundation Trust
Key inclusion & exclusion criteria

Inclusion Criteria:

• 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 Criteria:

- 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)



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All
Health Condition(s) or Problem(s) studied
Parkinson's Disease
Intervention(s)
Drug: Ursonorm
Primary Outcome(s)
Number of Participants that complete the study [Time Frame: Timepoint: start of treatment to 56 weeks (visit 6)]
Number of Participants with Incidence of Serious Adverse Events [Time Frame: Timepoint: start of treatment to 56 weeks (visit 6)]
Number of Participants with Incidence of Treatment-Emergent Adverse Events [Time Frame: Timepoint: start of treatment to 56 weeks (visit 6)]
Secondary Outcome(s)
Mean change from baseline to week 48 in in vivo parameter estimates of Adenosine Triphosphate (ATP) levels, derived from participant cranial 31P-Magnetic Resonance Spectroscopy (MRS) centered on the basal ganglia and related motor regions. [Time Frame: Timepoint: 48 weeks (visit 5)]
Mean change from baseline to week 48 in in vivo parameter estimates of Inorganic Phosphate (Pi) levels , derived from participant cranial 31P-Magnetic Resonance Spectroscopy (MRS) centered on the basal ganglia and related motor regions. [Time Frame: Timepoint: 48 weeks (visit 5)]
Mean change from baseline to week 48 in in vivo parameter estimates of Phosphocreatinine (PCr) levels, derived from participant cranial 31P-Magnetic Resonance Spectroscopy (MRS) centered on the basal ganglia and related motor regions. [Time Frame: Timepoint: 48 weeks (visit 5)]
Mean change from baseline to week 48 in objective quantification of participant motor impairment, using motion sensors. [Time Frame: Timepoint: 48 weeks (visit 5)]
Mean change from baseline to week 48 in participant scores on the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part 3 motor subsection in the "OFF" medication state. [Time Frame: Timepoint: 48 weeks (visit 5)]
Secondary ID(s)
2018-001887-46
STH18493
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Clinical Trials Research Unit, University of Sheffield
JP Moulton Charitable Foundation
PRO.MED.CS Praha a.s.
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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