Parkinson's disease
Conditions
Interventions
Trade Name: Bydureon 2 mg powder and solvent for prolonged-release suspension
for injection
Product Name: BYDUREON
Pharmaceutical Form: Powder and solvent for prolonged-release suspension for injectio
Sponsors
Stockholm Health Care Services
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Diagnosis of clinically probable Parkinson’s disease. • Males or Females. • Hoehn and Yahr stage = 2 in the ON medication state. • Patients are on levodopa treatment. • No need for extended treatment adjustment, no significant motor fluctuations during the last year. • All patients will be =25 and =80 years of age. • Ability to self-administer, or to arrange carer administration of the trial drug. • Signed informed consent to participate in the trial. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: • Atypical or other causes of parkinsonism. • 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. • Already actively participating in a trial of a device, drug or surgical treatment for Parkinson’s disease. • Previous exposure to Exenatide. • Known abnormality on CT or MRI brain imaging considered likely to compromise compliance with trial protocol/FDG-PET acquisition. • Patients with body mass index less than 18.5. • Patients with diabetes mellitus type 1. • Patients with prediabetes, or T2DM. • History of pancreatitis. • Severe gastrointestinal disease including gastroparesis. • History of alcoholism. • History of severe cardiac disease. • History of pancreas cancer. • History or suspicion of thyroid cancer. • Personal or family history of medullary thyroid cancer. • Patients with Multiple Endocrine Neoplasia 2 (MEN2) syndrome. • End-stage renal disease or creatinine clearance < 50 ml/min. • Hyperlipidaemia. • Concurrent treatment with warfarin. • Concurrent severe depression, defined as MADRS score more than 16. • Concurrent dementia, defined as MMSE < 22. • Pregnancy and Breastfeeding. • Known hypersensitivity or allergy or intolerance to GLP-1. • Known hypersensitivity to Exenatide or any of its excipients. • Potential participants who lack the capacity to give informed consent • Any medical, psychiatric or other condition which in the investigator’s opinion compromises the potential participant's ability to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To identify the biological mechanisms that mediate Exenatide-effect in the brain, and to measure true treatment-effect of Exenatide that is independent of the concurrent, symptomatic, dopaminergic treatment. To evaluate the effect on motor-symptom progression. (open-label extension part one). To evaluate the rate and severity of AEs and the number of AEs related to long-term exposure to Exenatide(open-label extension part two). ;Secondary Objective: - To compare the effect of Exenatide to placebo on disease progression. - To compare the effect of Exenatide to placebo on motor-symptom progression. - To compare the effect of Exenatide to placebo on the non-motor symptom progression. - To measure the safety of Exenatide in patients with PD. - To evaluate pharmacokinetic properties of Exenatide. - Frequency of adverse events (open-label extension part one). - To evaluate changes in motor, and non-motor symptoms activities of daily living and complications by dopaminergic treatment (open-label extension part one and two ). ;Primary end point(s): FDG-PET network analysis;Timepoint(s) of evaluation of this end point: Baseline, 9 and 21 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): A. MDS-UPDRS part 3 in OFF-medication state and accelerometer-based parameters of physical activity, MDS-UPDRS part 3 in ON-medication state, MDS-UPDRS parts 1, 2 and 4, biofluid-based parameters B. LEDD C. PDQ-39, NMSQuest, ESS, D. MoCA E. B-SIT F. MADRS;Timepoint(s) of evaluation of this end point: A. Baseline, 9, 18 and 21 months B. Baseline, 3, 6, 9, 12, 15, 18 and 21 months C. Baseline, 6, 12, 18 months D. Baseline, 9 and 21 months E. Baseline, 9 and 18 months F. Screening, 6, 12 and 18 months | — |
Countries
Sweden
Contacts
Public ContactAcademic Specialist Center
Stockholm Health Care Services
Outcome results
None listed