Trial of Exenatide for Parkinson's Disease

Launched by UNIVERSITY COLLEGE, LONDON · Oct 23, 2013

Keywords

ClinConnect Summary

This trial aims to generate further data to explore whether 48 weeks exposure to Exenatide has an advantage over placebo based on a standard validated assessment of Parkinson's disease severity (the MDS UPDRS part 3 motor subscale). This will be measured during the "practically defined OFF medication state" i.e. after patients have withheld their conventional PD medication overnight. The hypothesis is that Exenatide will be associated with reduced MDS UPDRS part 3 scores at the study end.

To further examine the safety and tolerability of 48 weeks exposure to Exenatide in patients with mode...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of Parkinson's disease.
• • Males or Females.
• • Hoehn and Yahr stage ≤ 2.5 in the On medication state.
• • Between 25 and 75 years of age.
• • On dopaminergic treatment with wearing off phenomena.
• • Ability to self-administer, or to arrange carer administration of trial drug.
• • Documented informed consent to participate.
• Exclusion Criteria:
• • Diagnosis or suspicion of other cause for parkinsonism.
• • Body mass index \<18.5.
• • Known abnormality on CT or MRI brain imaging considered likely to compromise compliance with trial protocol/DaTSCAN acquisition.
• • Concurrent dementia defined by a score lower than 120 on the Mattis Dementia Rating Scale.
• • Concurrent severe depression defined by a score \>16 on the MADRS.
• • Prior intra-cerebral surgical intervention for Parkinson's disease.
• • Already actively participating in a trial of a device, drug or surgical treatment for Parkinson's disease.
• • Severe gastrointestinal disease (e.g. gastroparesis).
• • Previous exposure to Exenatide.
• • Severely impaired renal function with creatinine clearance \<30ml/min.
• • History of pancreatitis.
• • Hyperlipidaemia.
• • History or suspicion of thyroid cancer
• • Known or suspected intolerance of DaTSCAN or Potassium Iodide administration.
• • Females that are pregnant or breast feeding.
• • 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.