Phase 3 Trial of exenatide for Parkinson’s disease
Research type
Research Study
Full title
A randomised, double blind, parallel group, placebo controlled, Phase 3 trial of exenatide once weekly over 2 years as a potential disease modifying treatment for Parkinson's disease.
IRAS ID
263481
Contact name
Thomas Foltynie
Contact email
Sponsor organisation
University College London Comprehensive Clinical Trial Unit
Eudract number
2018-003028-35
ISRCTN Number
ISRCTN14552789
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 5 months, 11 days
Research summary
This study is a clinical trial in patients with Parkinson's disease (PD), of a drug called exenatide, which is already licensed for the treatment of patients with type 2 diabetes. There have been several groups that have confirmed that exenatide has beneficial effects of nerve cells when tested in the laboratory, which raises the possibility that exenatide may slow down or stop the degeneration of PD. In an open label trial in patients with PD who self administered the drug for a period of 48 weeks, we have previously shown that the drug is well tolerated and shows encouraging effects on the movement and non-movement aspects of the disease. A double blind placebo controlled trial involving 60 participants was then conducted which indicated that exenatide may be a "neuroprotective" drug, i.e. one that stops the nerve cells dying in PD. The next step is therefore to confirm this "neuroprotective" effect and to see whether this effect can be reproduced in a multi-centre setting including a larger number of participants. An important objective is to explore whether any positive effects remain static or increase when the treatment is continued over a 96 week period.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
19/SC/0447
Date of REC Opinion
4 Sep 2019
REC opinion
Favourable Opinion