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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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28 November 2016 |
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Main ID: |
NCT01971242 |
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Date of registration:
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23/10/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Trial of Exenatide for Parkinson's Disease
EXENATIDE-PD |
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Scientific title:
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A Randomised, Double Blind, Placebo Controlled, Single Centre, 60 Week Trial of Exenatide Once Weekly for the Treatment of Moderate Severity Parkinson's Disease |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01971242 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Thomas Foltynie, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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UCL Institute of Neurology |
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Key inclusion & exclusion criteria
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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.
Age minimum:
25 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Drug: Exenatide
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Other: Placebo
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Primary Outcome(s)
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Efficacy
[Time Frame: 60 weeks]
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Secondary Outcome(s)
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Safety and tolerability
[Time Frame: 60 weeks]
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Secondary ID(s)
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2013-003363-64
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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