Parkinson's disease MedDRA version: 14.1 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Byetta 5 micrograms
Product Name: Exenatide 5 micrograms
Pharmaceutical Form: Solution for injection
Trade Name: Exenatide 10 micrograms
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosis of Idiopathic Parkinson’s disease of moderate severity- equivalent to Hoehn/ Yahr stage 2 or 3 (Bilateral symptoms but still physically independent). Male or female. Female patients to be post menopausal (defined as 12 months of spontaneous amenorrhoea or 6 months spontaneous amenorrhoea with FSH levels greater than 40mIU/ml), surgically sterilised (post hysterectomy and/or oophorectomy) or who use adequate contraception (oral contraceptives, IUD, or double barrier methods i.e. condom + diaphragm, or condom & diaphragm + spermicidal gel/foam) throughout the duration of the trial period. Age 45-70 years Disease onset after age 40 years Disease duration > 5 years On L-dopa treatment. Patient must be on oral L-dopa treatment - with or without dopamine agonist including Apomorphine, MAO-B inhibitor, COMT inhibitor, Amantadine, Beta blocker, anticholinergic treatment History of wearing off phenomena- duration of action of single dose of L-dopa 15 L-dopa responsiveness. Defined as >33% improvement in UPDRS motor off medication score following L-dopa challenge Able to give informed consent Able to comply with trial protocol and willing to attend clinic necessary visits Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Diagnosis or suspicion of other cause for parkinsonism including Vascular parkinsonism, post traumatic parkinsonism, drug or toxin induced parkinsonism, or other neurodegenerative condition including Multiple System Atrophy, Progressive Supranuclear Palsy, Huntington’s disease, Wilson’s disease, Pantothenate Kinase Associated Neurodegeneration, Alzheimer’s disease, Creutzfeld Jacob disease. Known abnormality on CT or MRI brain imaging considered to be causing symptoms or signs of neurological dysfunction, or considered likely to compromise compliance with trial protocol. Concurrent dementia defined by a score lower than 120 on the Mattis Dementia Rating Scale. Concurrent severe depression defined by a score greater than 16 on the MADRS Exposure to neuroleptic drugs within 6 months prior to baseline assessment Prior intracerebral surgical intervention for Parkinson’s disease including Deep Brain stimulation, lesional surgery, growth factor administration, gene therapy or cell transplant 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 End stage renal disease or severely impaired renal function with creatinine clearance <30ml/min History of severe cardiac disease (Angina, Myocardial infarction or cardiac surgery in preceding 2 years) History of pancreatitis History of alcoholism Severe gastrointestinal disease including gastroparesis Ongoing treatment with sulphonylurea Pregnancy or breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To collect pilot data from which to estimate the effectiveness of Exenatide in modifying the progression of the motor symptoms of patients with moderate severity of Parkinson’s disease, using a validated scale -the UPDRS off medication motor score as the main primary outcome measure.; Secondary Objective: -To confirm the safety and tolerability of Exenatide among patients with moderate PD. -To identify whether Exenatide treatment leads to any changes in (FP-CIT) DATscan appearances among patients with moderate PD. -To evaluate the impact of Exenatide on activities of daily living, dyskinesias, timed motor tests, cognitive ability, mood, behaviour, non-motor symptoms and quality of life among patients with moderate PD using standard validated tools of assessment. ;Primary end point(s): The primary outcome is the 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. | — |
Countries
United Kingdom
Outcome results
None listed