Exenatide Once Weekly Over 2 Years as a Potential Disease Modifying Treatment for Parkinson's Dis… (NCT04232969) | Clinical Trial Compass
CompletedPhase 3
Exenatide Once Weekly Over 2 Years as a Potential Disease Modifying Treatment for Parkinson's Disease
United Kingdom194 participantsStarted 2020-01-20
Plain-language summary
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. There have been several groups that have confirmed that exenatide has beneficial effects of nerve cells when tested in the laboratory, which raises the possibility that exenatide may slow down or stop the degeneration of PD. In an open label trial in patients with PD who self administered the drug for a period of 48 weeks, the investigators have previously shown that the drug is well tolerated and shows encouraging effects on the movement and non-movement aspects of the disease. A double blind placebo controlled trial involving 60 participants was then conducted which indicated that exenatide may be a "neuroprotective" drug, i.e. one that stops the nerve cells dying in PD. The next step is therefore to confirm this "neuroprotective" effect and to see whether this effect can be reproduced in a multi-centre setting including a larger number of participants. An important objective is to explore whether any positive effects remain static or increase when the treatment is continued over a 96 week period. In order to explore this, a randomised, double blind, parallel group, placebo controlled, Phase 3 trial of Exenatide is being undertaken (Exenatide-PD3).
Who can participate
Age range25 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Documented informed consent to participate.
Exclusion criteria
✕. 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.
✕. Known abnormality on CT or MRI brain imaging considered likely to compromise compliance with trial protocol.
What they're measuring
1
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3
. Significant cognitive impairment defined by a score \<21 on the Montreal Cognitive Assessment.
✕. Concurrent severe depression defined by a score ≥16 on the Patient Health Questionnaire (PHQ-9).
✕. Prior intra-cerebral surgical intervention for Parkinson's disease.
✕. 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).