Trial of Exenatide for Parkinson's Disease (EXENATIDE-PD)
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ClinicalTrials.gov Identifier: NCT01971242 |
Recruitment Status :
Completed
First Posted : October 29, 2013
Last Update Posted : November 17, 2016
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Condition or disease | Intervention/treatment | Phase |
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Parkinson's Disease | Drug: Exenatide Other: Placebo | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
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 |
Study Start Date : | June 2014 |
Actual Primary Completion Date : | May 2016 |
Actual Study Completion Date : | August 2016 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Exenatide
Bydureon- 2mg administered subcutaneously once weekly
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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
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Other: Placebo
Placebo, 2mg, SC (subcutaneous), once weekly for 48 weeks. |
- 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.
- 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
- 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)

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Ages Eligible for Study: | 25 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01971242
United Kingdom | |
National Hospital for Neurology & Neurosurgery (part of UCLH NHS Trust) | |
London, United Kingdom, WC1N 3BG |
Principal Investigator: | Thomas Foltynie, Dr | UCL Institute of Neurology |
Responsible Party: | University College, London |
ClinicalTrials.gov Identifier: | NCT01971242 |
Other Study ID Numbers: |
2013-003363-64 |
First Posted: | October 29, 2013 Key Record Dates |
Last Update Posted: | November 17, 2016 |
Last Verified: | March 2015 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | No plans to share individual participant data (IPD) |
Parkinson's Parkinson's Disease Exenatide Bydureon |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Synucleinopathies |
Neurodegenerative Diseases Exenatide Hypoglycemic Agents Physiological Effects of Drugs Anti-Obesity Agents Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |