Exenatide once weekly over 2 years as a potential disease-modifying treatment for Parkinson's disease: protocol for a multicentre, randomised, double blind, parallel group, placebo controlled, phase 3 trial: The 'Exenatide-PD3' study

What Was Tested

Researchers studied Exenatide in the context of parkinson's disease in this clinical study publication.

Parkinson's disease (PD) is a common neurodegenerative disorder with substantial morbidity.

No disease-modifying treatments currently exist.

Who Took Part

According to the abstract, 200 participants were involved.

Treatment duration is 96 weeks.

Assessments are performed at baseline, week 12, 24, 36, 48, 60, 72, 84 and 96 weeks.The primary outcome is the comparison of Movement Disorders Society Unified Parkinson's Disease Rating Scale part 3 motor subscore in the practically defined OFF medication state at 96 weeks between participants according to treatment allocation.

How the Study Was Run

In design terms this was a randomized, double-blind, placebo-controlled and multicenter study.

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

As a double-blind Exenatide study, the assignments were hidden from both participants and investigators until the end.

The comparison arm used a placebo, so changes seen with Exenatide could be set against what happens without it.

Running at several centres spread the Exenatide study over different clinics and patient groups.

Randomisation is 1:1, drug to placebo.

Secondary outcomes will compare the change between groups among other motor, non-motor and cognitive scores.

The primary outcome will be reported using descriptive statistics and comparisons between treatment groups using a mixed model, adjusting for baseline scores.

What Was Measured

PubMed files the paper under topics including Clinical Trials, Phase III as Topic, Exenatide, Parkinson Disease and Randomized Controlled Trials as Topic.

The authors tagged it with the keywords Parkinson-s disease, public health and qualitative research.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Exenatide in 200 participants in people with parkinson's disease.

The publication is from 2021 (BMJ open), a journal based in England.

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