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Trial · Interventional

CompletedPhase 2Registry data

Trial of Exenatide for Parkinson's Disease

Short name EXENATIDE-PD

NCTNCT01971242 (opens ClinicalTrials.gov in a new tab)Other id2013-003363-64
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
60 participants (actual)
Sponsor
University College, London · Other
Design
Randomized · Triple masking
Countries
1 country

United Kingdom

Start
Jun 2014
Primary completion
May 2016
Completion
Aug 2016
First posted
29 Oct 2013 (estimated)
Last update posted
17 Nov 2016 (estimated)
Conditions
Parkinson's Disease

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2014201520162017
  1. Ph 2

    EXENATIDE-PD

    NCT01971242

    Jun 2014 to Aug 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • ExenatideDrug
  • PlaceboOther

Arms2

  • Active comparator

    Exenatide

    Bydureon- 2mg administered subcutaneously once weekly

  • Placebo comparator

    Placebo

    Placebo, 2mg administered subcutaneously once weekly

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Efficacy

    Time frame · 60 weeks

    Registry description

    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 outcomes(1)

  1. Safety and tolerability

    Time frame · 60 weeks

    Registry description

    • 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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2017

4 results

Exenatide once weekly versus placebo in Parkinson's disease: a randomised, double-blind, placebo-controlled trial.

Athauda et al. 2017Lancet (London, England)cited by 719

PMID 28781108PMC5831666DOI 10.1016/s0140-6736(17)31585-4PUB-28781108

Rights unknown4 results
Source linkSee results (4)

Eligibility

Who could join, as posted.

Sex
All
Age
from 25 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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