Trial of Ursodeoxycholic Acid (UDCA) for Parkinson's Disease: The "UP" Study
Status:
Completed
Trial end date:
2021-05-13
Target enrollment:
Participant gender:
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 concept" study. The primary objective of the study will be to
determine the safety and tolerability of this drug in patients with PD. Participants will be
recruited form a cohort of patients who have been diagnosed with PD within the last 3 years
and are potentially suitable for this study.
There is strong evidence from previous research and the work carried out by other groups that
UDCA rescues the function of the mitochondria (mitochondria are the "powerhouse" of the cell)
in PD patient tissue and other models of PD. This suggests that UDCA may slow down the
worsening of PD.
UDCA has been in clinical use for the treatment of liver disease (primary biliary
cholangitis) for over 30 years. The investigators therefore know that it is safe and well
tolerated in patients with liver disease but the investigators don't know yet whether this is
also the case in patients with PD. Furthermore, the dose used for patients with liver disease
(15 mg/kg) is not high enough for UDCA to get into the brain. The investigators therefore
need to double the dose to 30 mg/kg. This higher dose was also safe in clinical trials for
liver disease, but is currently not used routinely in clinical practice.
Phase:
Phase 2
Details
Lead Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators:
Clinical Trials Research Unit, University of Sheffield J P Moulton Charitable Foundation JP Moulton Charitable Foundation PRO.MED.CS Praha a.s.