A trial of Exenatide for the treatment of moderate severity Parkinson's disease

Not Applicable

Completed

• Conditions: Topic: Dementias and Neurodegenerative Diseases Research Network; Subtopic: Parkinson?s Disease; Disease: Parkinson's disease; Nervous System Diseases; Parkinson disease

• Registration Number: ISRCTN75891427
• Lead Sponsor: niversity College London (UK)

Brief Summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28781108

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-24
• Study Completion: 2016-03-01
• Last Update Posted: 18 June 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Diagnosis of Parkinson's disease
2. Males or females
3. Hoehn and Yahr stage = 2.5 in the on medication state
4. Between 25 and 75 years of age
5. On dopaminergic treatment with wearing off phenomena
6. Ability to self-administer, or to arrange carer administration of trial drug
7. Documented informed consent to participate

Exclusion Criteria

1. Diagnosis or suspicion of other cause for Parkinsonism. Subject without DaTscan appearances consistent with diagnosis of PD will not be eligible
2. Body mass index <18.5
3. Known abnormality on CT or MRI brain imaging considered likely to compromise compliance with trial protocol/DaTSCAN acquisition
4. Concurrent dementia defined by a score lower than 120 on the Mattis Dementia Rating Scale
5. Concurrent severe depression defined by a score >16 on the MADRS
6. Prior intra-cerebral surgical intervention for Parkinson's disease
7. Already actively participating in a trial of a device, drug or surgical treatment for Parkinson's disease
8. Previous exposure to Exenatide
9. Severely impaired renal function with creatinine clearance <30 ml/min
10. History of pancreatitis
11. Severe gastrointestinal disease (e.g., gastroparesis)
12. Hyperlipidaemia
13. History or suspicion of thyroid cancer
14. Known or suspected intolerance of DaTSCAN or Potassium Iodide administration
15. Females that are pregnant or breast feeding. Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and up to 4 weeks after the last dose of study drug
16. Participants who lack the capacity to give informed consent
17. Any medical or psychiatric condition which in the investigator's opinion compromises the potential participant's ability to participate

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Motor score in practically defined 'OFF' medication state; Timepoint(s): 60 weeks (i.e. 12 weeks following end of treatment).

Secondary Outcome Measures

Name	Time	Method
Differences at 48 and 60 weeks for each of the secondary outcomes will be compared between groups according to treatment allocation (using ANCOVA to adjust for differences at baseline)