Clinical trial NCT01174810 (phase 2, status: unknown status)
Conditions: parkinson's disease
ICD codes: G20
Drugs: exenatide
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O
Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Idiopathic Parkinson's disease of moderate severity- equivalent to Hoehn/
             Yahr stage 2 to 2.5 (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). Male patients with female
        partners that have child bearing potential must use adequate contraception (condoms
        +/-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 < 6 hours Stable PD medication for preceding 3 months-
             i.e. no change in medication type or dose.

          -  UPDRS motor off medication score >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 necessary clinic visits off
             medication.

        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
             Neurodegeneration (PKAN), 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

          -  Females that are pregnant or breast feeding or of child bearing potential.