Parkinson's Disease Clinical Trial
Official title:
An Open Label, Single Site, 12 Month, Phase II, Randomised Controlled Trial Evaluating the Safety and Efficacy of Exendin-4 (Exenatide) in the Treatment of Patients With Moderate Severity Parkinson's Disease.
Exenatide is a licensed, safe and effective treatment for patients with Diabetes mellitus.
Laboratory work has shown strong, reproducible evidence that this drug has beneficial
"disease modifying" effects when given to animals with a range of experimental models of
Parkinson's disease (PD). This project aims to make an initial evaluation of possible
benefits of Exenatide among patients with moderate symptoms of PD. The drug will be given as
a twice daily 10microgram injection under the skin in a similar way to one of the
conventional "symptomatic" treatments for PD (Apomorphine).
Forty patients with moderate symptoms of PD will be recruited and randomised to receive
Exenatide injections twice daily, or to act as controls in this open label trial. Detailed
assessments will be made of all patients at baseline and periodically for a total of 14
months. The primary outcome measure will be the change between baseline and follow up, in
the severity of a validated PD assessment scale (the UPDRS part 3 motor score) after an
overnight period free of conventional PD medication. Secondary measures will include adverse
event reports, self completed questionnaires, and blood test results. Aside from these
assessments, all patients will continue their regular PD medications throughout the trial
with adjustments made only according to clinical need.
In a subgroup of patients (n=10), brain scans that assess the severity of PD, will be
performed at both baseline and follow up to help understand possible mechanisms of action of
Exenatide.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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