A randomised, double-blind, placebo-controlled, single-centre, 60-week trial of Exenatide once weekly for the treatment of moderate severity Parkinson's disease

niversity College London (UK)0 sites60 target enrollmentJanuary 24, 2014

Overview

Phase: 未知
Intervention: Not specified
Conditions: Topic: Dementias and Neurodegenerative Diseases Research Network
Sponsor: niversity College London (UK)
Enrollment: 60
Status: Completed
Last Updated: 7 years ago

Registry

who.int

Start Date

January 24, 2014

End Date

March 1, 2016

Last Updated

7 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity College London (UK)

•1\. Diagnosis of Parkinson's disease
•2\. Males or females
•3\. Hoehn and Yahr stage \= 2\.5 in the on medication state
•4\. Between 25 and 75 years of age
•5\. On dopaminergic treatment with wearing off phenomena
•6\. Ability to self\-administer, or to arrange carer administration of trial drug
•7\. Documented informed consent to participate

•1\. Diagnosis or suspicion of other cause for Parkinsonism. Subject without DaTscan appearances consistent with diagnosis of PD will not be eligible
•2\. Body mass index \<18\.5
•3\. Known abnormality on CT or MRI brain imaging considered likely to compromise compliance with trial protocol/DaTSCAN acquisition
•4\. Concurrent dementia defined by a score lower than 120 on the Mattis Dementia Rating Scale
•5\. Concurrent severe depression defined by a score \>16 on the MADRS
•6\. Prior intra\-cerebral surgical intervention for Parkinson's disease
•7\. Already actively participating in a trial of a device, drug or surgical treatment for Parkinson's disease
•8\. Previous exposure to Exenatide
•9\. Severely impaired renal function with creatinine clearance \<30 ml/min
•10\. History of pancreatitis