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Trial record 1 of 1 for:    EXENATIDE-PD
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Trial of Exenatide for Parkinson's Disease (EXENATIDE-PD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT01971242
First received: October 23, 2013
Last updated: November 16, 2016
Last verified: March 2015
  Purpose
This study is a clinical trial in patients with Parkinson's disease, 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 on nerve cells when tested in the laboratory, that raises the possibility that Exenatide may slow down or stop the degenerative process of Parkinson's disease. In an open label trial in patients with Parkinson's disease who self administered the drug for 1 year, we have previously shown that the drug is well tolerated and shows encouraging effects on the movement and non-movement aspects of the disease, even 2 months after patients stopped administering the drug. The next step is therefore to formally evaluate whether Exenatide really is a potential "neuroprotective" drug, i.e. stops the nerve cells dying in Parkinson's disease, by conducting a double blind, placebo controlled trial.

Condition Intervention Phase
Parkinson's Disease Drug: Exenatide Other: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double Blind, Placebo Controlled, Single Centre, 60 Week Trial of Exenatide Once Weekly for the Treatment of Moderate Severity Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 60 weeks ]
    The primary objective is to compare the effectiveness of Exenatide versus placebo on the MDS UPDRS part 3 motor subscale in the "practically defined OFF medication state" in patients with moderate severity PD.


Secondary Outcome Measures:
  • Safety and tolerability [ Time Frame: 60 weeks ]

    • Compare differences at 48 and 60 weeks between the Exenatide and placebo trial arms in:

    • Movement Disorder Society Unified Parkinson's Disease Rating Scale part 1,2,3 and 4 On medication scores
    • Movement Disorder Society Unified Parkinson's Disease Rating Scale part 3 Motor subsection Off medication score at 48 weeks.
    • Mattis Dementia Rating scale (DRS-2).
    • Safety and tolerability of Exenatide as indicated by changes in Vital signs, weight, clinical laboratory measures and Adverse Effects


Other Outcome Measures:
  • Exploratory outcomes [ Time Frame: Compare differences at 48 and 60 weeks ]

    Exploratory outcomes:

    • Compare differences at 48 and 60 weeks between the Exenatide and placebo trial arms in:

    • Unified Dyskinesia Rating scale
    • 3 day Hauser diary of PD state (Time-On, Off, Non troublesome Dyskinesia, Troublesome dyskinesia, Asleep)
    • Montgomery and Asberg Depression Rating Scale (MADRS)
    • Parkinson's Disease 39 item Quality of life questionnaire (PDQ39)
    • Non-Motor Symptoms scale (NMSS)
    • Levodopa equivalent doses (LED)
    • Quantitative change in Dopamine Transporter availability as measured by DaTSCAN uptake between baseline and 60 week evaluations
    • Exenatide level in blood, urine every 12 weeks, CSF (at 12 and 48 weeks)
    • CSF levels of BDNF (at 12 and 48 weeks)


Enrollment: 60
Study Start Date: June 2014
Study Completion Date: August 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Exenatide
Bydureon- 2mg administered subcutaneously once weekly
Drug: Exenatide
2mg, SC (subcutaneous) once weekly. Number of weeks: 48 weeks. Exenatide is a 39-amino-acid peptide
Other Name: Bydureon
Placebo Comparator: Placebo
Placebo, 2mg administered subcutaneously once weekly
Other: Placebo
Placebo, 2mg, SC (subcutaneous), once weekly for 48 weeks.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Parkinson's disease.
  • Males or Females.
  • Hoehn and Yahr stage ≤ 2.5 in the On medication state.
  • Between 25 and 75 years of age.
  • On dopaminergic treatment with wearing off phenomena.
  • Ability to self-administer, or to arrange carer administration of trial drug.
  • Documented informed consent to participate.

Exclusion Criteria:

  • Diagnosis or suspicion of other cause for parkinsonism.
  • Body mass index <18.5.
  • Known abnormality on CT or MRI brain imaging considered likely to compromise compliance with trial protocol/DaTSCAN acquisition.
  • Concurrent dementia defined by a score lower than 120 on the Mattis Dementia Rating Scale.
  • Concurrent severe depression defined by a score >16 on the MADRS.
  • Prior intra-cerebral surgical intervention for Parkinson's disease.
  • Already actively participating in a trial of a device, drug or surgical treatment for Parkinson's disease.
  • Severe gastrointestinal disease (e.g. gastroparesis).
  • Previous exposure to Exenatide.
  • Severely impaired renal function with creatinine clearance <30ml/min.
  • History of pancreatitis.
  • Hyperlipidaemia.
  • History or suspicion of thyroid cancer
  • Known or suspected intolerance of DaTSCAN or Potassium Iodide administration.
  • Females that are pregnant or breast feeding.
  • Participants who lack the capacity to give informed consent
  • Any medical or psychiatric condition which in the investigator's opinion compromises the potential participant's ability to participate.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01971242

Locations
United Kingdom
National Hospital for Neurology & Neurosurgery (part of UCLH NHS Trust)
London, United Kingdom, WC1N 3BG
Sponsors and Collaborators
University College, London
Investigators
Principal Investigator: Thomas Foltynie, Dr UCL Institute of Neurology
  More Information

Additional Information:
Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01971242     History of Changes
Other Study ID Numbers: 2013-003363-64
Study First Received: October 23, 2013
Last Updated: November 16, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plans to share individual participant data (IPD)

Keywords provided by University College, London:
Parkinson's
Parkinson's Disease
Exenatide
Bydureon

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 19, 2017