Exenatide Once Weekly Over 2 Years as a Potential Disease Modifying Treatment for Parkinson's Disease

What Was Tested

In this phase 3 trial, researchers set out to test Exenatide for parkinson's disease.

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.

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

Exenatide extended release placebo once weekly for 96 weeks n=100.

The registry classes the interventions as drug.

Who Took Part

The registry lists 194 actual participants took part.

It was open to people of any sex aged from 25 years up to 80 years.

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

Examples of who could join: Diagnosis of Parkinson's disease. Hoehn and Yahr stage ≤2.5 in the ON medication state. Between 25 and 80 years of age. On dopaminergic treatment for at least 4 weeks before enrolment. Ability to self-administer, or to arrange carer administration of trial medication.

The full record lists 6 inclusion and 22 exclusion criteria; among the exclusions: diagnosis or suspicion of other cause for parkinsonism; patients unable to attend the clinic visits in the practically defined off medication state; body mass index \<18.5.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this Exenatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Exenatide group and the comparison group ran side by side rather than switching.

Neither the parkinson's disease participants nor the staff measuring them knew who was on Exenatide, so expectations could not easily colour the readings.

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

It started in 2020-01-20 with completion listed for 2024-02-24.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3 (time frame: 96 weeks).

It also tracked 45 secondary outcomes, for example Movement Disorder Society Unified Parkinson's Disease Rating Scale part 1,2, and 4 ON medication scores, Timed Walk assessment ON and OFF medication, Montreal Cognitive Assessment, Unified Dyskinesia Rating Scale (UDysRS), Patient Health Questionnaire-9 (PHQ-9) and Parkinson's Disease 39 item Quality of life questionnaire.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide in 194 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.