A randomised, double-blind, parallel-group, placebo-controlled, Phase 3 trial of exenatide once weekly over 2 years as a potential disease-modifying treatment for Parkinson's disease

niversity College London0 sites194 target enrollmentOctober 8, 2019

ConditionsParkinson’s disease Nervous System Diseases Parkinson disease

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Parkinson’s disease
Sponsor: niversity College London
Enrollment: 194
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34049922/ (added 01/06/2021)

Registry

who.int

Start Date

October 8, 2019

End Date

July 31, 2024

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

niversity College London

Eligibility Criteria

Inclusion Criteria

•1\. Diagnosis of Parkinson’s disease. PD is a clinical diagnosis and is based on the opinion of the PI or delegate on site after review of the clinical history, examination findings and response to PD medication. The Queen Square brain bank criteria MAY be used to help assist in the diagnosis, although this need not be a formal inclusion criteria, and the relevance of a positive family history of PD, or a confirmed genetic basis for an individual’s symptoms will be evaluated in the context of other clinical features in determining diagnosis and eligibility
•2\. Hoehn and Yahr stage \< \= 2\.5 in the ON medication state. This implies that all patients will be mobile without assistance during their best ON” medication periods
•3\. Between 25 and 80 years of age
•4\. On dopaminergic treatment for at least 4 weeks before enrolment. All participants must have had previous or ongoing exposure to dopaminergic treatment either as L\-dopa or a dopamine agonist. If L\-dopa has been stopped due to side effects or lack of response, the local PI should further confirm that the participant has clinical symptoms and signs and/or radiological investigations consistent with a diagnosis of Parkinson’s disease
•5\. Ability to self\-administer, or to arrange carer administration of trial medication
•6\. Documented informed consent to participate

Exclusion Criteria

•1\. Diagnosis or suspicion of other cause for Parkinsonism. Patients with clinical features indicating a diagnosis of Progressive Supranuclear Palsy, Multiple Systems Atrophy, Drug\-induced Parkinsonism, Dystonic tremor or Essential tremor will not be recruited.
•2\. Patients unable to attend the clinic visits in the practically defined OFF medication state.
•3\. Body mass index \< 18\.5\. (Exenatide is known to cause weight loss therefore individuals that may not tolerate further weight loss will not be recruited).
•4\. Known abnormality on CT or MRI brain imaging considered likely to compromise compliance with trial protocol.
•5\. Significant cognitive impairment defined by a score \< 21 on the Montreal Cognitive Assessment.
•6\. Concurrent severe depression defined by a score \> \= 16 on the Patient Health Questionnaire (PHQ\-9\).
•7\. Prior intra\-cerebral surgical intervention for Parkinson’s disease. Patients who have previously undergone Deep Brain Stimulation, intra\-cerebral administration of growth factors, gene therapy or cell therapies will not be eligible.
•8\. Previous participation in one of the following Parkinson’s disease trials (Biogen SPARK trial, Prothena Pasadena trial, Sanofi Genzyme MOVES\-PD trial, UDCA\-PD UP Study or any other trial still considered to involve a potentially PD modifying agent).
•9\. Participation in another clinical trial of a device, drug or surgical treatment within the last 30 days.
•10\. Previous exposure to exenatide.