Study to Evaluate the Effect of Lixisenatide in Patient With Parkinson's Disease

What Was Tested

This registered phase 2 trial tested Lixisenatide for parkinson's disease.

It had two arms (groups): Lixisenatide (experimental) and Placebo (placebo comparator).

Placebo: once daily subcutaneous injection.

The registry classes the interventions as drug.

More on the Plan

The treatment period will be followed by a wash-out period of 2 months.

None of these treatments can slow down the underlining disease process and the relentless progression of motor and non-motor disability.

Several mechanisms including the aggregation of misfolded alphasynuclein, mitochondrial dysfunction, oxidative stress and neuroinflammation have been related to the pathogenesis of PD.

GLP1-R are widely expressed in the central nervous system and GLP1-R agonists such as liraglutide, lixisenatide and exenatide have measurable brain concentrations, which makes them suitable for treating brain disorders.

Who Took Part

Enrollment: 156 actual participants took part.

It was open to people of any sex aged from 40 years up to 75 years.

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

Examples of who could join: Patients with PD according to UKPDSBB criteria (male or female). Patient with a Hoehn and Yahr Stage \<3 in the ON condition. Patients aged from 40 to 75 years old. Early-stage PD patients: diagnosis of PD for less than 3 years, without dyskinesia and motor fluctuations. Patients treated with an "optimized" stable dopaminergic medication regimen (dopamine agonist and/or L-dopa and/or MAOB inhibitor) for at least 1 month before baseline.

The full record lists 9 inclusion and 28 exclusion criteria; among the exclusions: patients with a body mass index \< 18.5; patients suffering from type 1 or type 2 diabetes; weight change of more than 5 kg in body weight during the last 3 months prior to screening.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

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

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

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

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

It started in 2018-06-13 with completion listed for 2021-04-15.

It ran at 20 sites in France (20).

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Lixisenatide in 156 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 Lixisenatide compound page, Parkinson's disease research.