Exendin-4 as a Treatment for Parkinson's Disease - Pilot Study

Plain-language guide to NCT01174810: phase 2 randomized trial of Exenatide, parkinson's disease, 40 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT01174810
Phase: phase 2
Status: status unknown
Start: 2010-07
Completion (planned or actual): 2013-03
Participants: 40 (estimated)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Parkinson's Disease
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

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

It had two arms (groups): Control (no intervention) and Exenatide (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 40 planned participants were the target.

It was open to people of any sex aged from 45 years up to 70 years.

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

Examples of who could join: Diagnosis of Idiopathic Parkinson's disease of moderate severity- equivalent to Hoehn/ Yahr stage 2 to 2.5 (Bilateral symptoms but still physically independent). Age 45-70 years. Disease onset after age 40 years. Disease duration \> 5 years. UPDRS motor off medication score \>15.

The full record lists 9 inclusion and 13 exclusion criteria; among the exclusions: already actively participating in a trial of a device, drug or surgical treatment for parkinson's disease, or trial participation within previous 30 days; type 1 diabetes mellitus; type 2 diabetes mellitus on insulin treatment.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Exenatide and who got the comparison, which limits bias.

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

Nothing was hidden in this open-label Exenatide study: the parkinson's disease participants and staff both knew the treatment.

It started in 2010-07 with completion listed for 2013-03.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change from baseline to 12 months & 14 months between patients on active Exenatide treatment and PD controls in respect of their UPDRS-off-medication motor subscore.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Exenatide in 40 people with parkinson's disease.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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

Our Notes on the Compound

Exenatide: A 39-amino-acid GLP-1 receptor agonist first identified in Gila monster venom; sold as Byetta and Bydureon for type 2 diabetes.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.