Trial of Exenatide for Parkinson's Disease

What Was Tested

In this phase 2 trial, researchers set out to test Exenatide for parkinson's disease.

This study is a clinical trial in patients with Parkinson's disease, of a drug called Exenatide which is already licensed for the treatment of patients with Type 2 Diabetes.

It had two arms (groups): Exenatide (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

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.

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

The researchers hypothesise that any central effects of Exenatide will be mediated through penetration of Exenatide across the blood brain barrier.

Who Took Part

60 actual participants took part.

It was open to people of any sex aged from 25 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 7 inclusion and 17 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

The parkinson's disease participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

Groups ran in parallel: each of the parkinson's disease participants stayed in one arm throughout.

Blinding on both sides kept the parkinson's disease participants and researchers unaware of who received Exenatide.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2014-06 with completion listed for 2016-05.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example Safety and tolerability.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Exenatide in 60 people with parkinson's disease.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page, Parkinson's disease research.