Parkinson's Disease Clinical Trial
Official title:
An Open Label, Single Site, 12 Month, Phase II, Randomised Controlled Trial Evaluating the Safety and Efficacy of Exendin-4 (Exenatide) in the Treatment of Patients With Moderate Severity Parkinson's Disease.
Exenatide is a licensed, safe and effective treatment for patients with Diabetes mellitus.
Laboratory work has shown strong, reproducible evidence that this drug has beneficial
"disease modifying" effects when given to animals with a range of experimental models of
Parkinson's disease (PD). This project aims to make an initial evaluation of possible
benefits of Exenatide among patients with moderate symptoms of PD. The drug will be given as
a twice daily 10microgram injection under the skin in a similar way to one of the
conventional "symptomatic" treatments for PD (Apomorphine).
Forty patients with moderate symptoms of PD will be recruited and randomised to receive
Exenatide injections twice daily, or to act as controls in this open label trial. Detailed
assessments will be made of all patients at baseline and periodically for a total of 14
months. The primary outcome measure will be the change between baseline and follow up, in
the severity of a validated PD assessment scale (the UPDRS part 3 motor score) after an
overnight period free of conventional PD medication. Secondary measures will include adverse
event reports, self completed questionnaires, and blood test results. Aside from these
assessments, all patients will continue their regular PD medications throughout the trial
with adjustments made only according to clinical need.
In a subgroup of patients (n=10), brain scans that assess the severity of PD, will be
performed at both baseline and follow up to help understand possible mechanisms of action of
Exenatide.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02915848 -
Long-term Stability of LFP Recorded From the STN and the Effects of DBS
|
||
| Recruiting |
NCT03648905 -
Clinical Laboratory Evaluation of Chronic Autonomic Failure
|
||
| Terminated |
NCT02688465 -
Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE).
|
Phase 4 | |
| Completed |
NCT05040048 -
Taxonomy of Neurodegenerative Diseases : Observational Study in Alzheimer's Disease and Parkinson's Disease
|
||
| Active, not recruiting |
NCT04006210 -
Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations
|
Phase 3 | |
| Completed |
NCT02562768 -
A Study of LY3154207 in Healthy Participants and Participants With Parkinson's Disease
|
Phase 1 | |
| Completed |
NCT00105521 -
Sarizotan in Participants With Parkinson's Disease Suffering From Treatment Associated Dyskinesia
|
Phase 3 | |
| Completed |
NCT00105508 -
Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia
|
Phase 3 | |
| Recruiting |
NCT06002581 -
Repetitive Transcranial Magnetic Stimulation(rTMS) Regulating Slow-wave to Delay the Progression of Parkinson's Disease
|
N/A | |
| Completed |
NCT02236260 -
Evaluation of the Benefit Provided by Acupuncture During a Surgery of Deep Brain Stimulation
|
N/A | |
| Completed |
NCT00529724 -
Body Weight Gain, Parkinson, Subthalamic Stimulation
|
Phase 2 | |
| Active, not recruiting |
NCT05699460 -
Pre-Gene Therapy Study in Parkinson's Disease and Multiple System Atrophy
|
||
| Completed |
NCT03703570 -
A Study of KW-6356 in Patients With Parkinson's Disease on Treatment With Levodopa-containing Preparations
|
Phase 2 | |
| Completed |
NCT03462680 -
GPR109A and Parkinson's Disease: Role of Niacin in Outcome Measures
|
N/A | |
| Completed |
NCT02837172 -
Diagnosis of PD and PD Progression Using DWI
|
||
| Not yet recruiting |
NCT04046276 -
Intensity of Aerobic Training and Neuroprotection in Parkinson's Disease
|
N/A | |
| Recruiting |
NCT02952391 -
Assessing Cholinergic Innervation in Parkinson's Disease Using the PET Imaging Marker [18F]Fluoroethoxybenzovesamicol
|
N/A | |
| Active, not recruiting |
NCT02937324 -
The CloudUPDRS Smartphone Software in Parkinson's Study.
|
N/A | |
| Completed |
NCT02939391 -
A Study of KW-6356 in Subjects With Early Parkinson's Disease
|
Phase 2 | |
| Terminated |
NCT02894567 -
Evaluation of Directional Recording and Stimulation Using spiderSTN
|
N/A |