DRUG
Exenatide extended release 2mg (Bydureon)
Subcutaneous Injection
Exenatide Once Weekly Over 2 Years as a Potential Disease Modifying Treatment for Parkinson's Disease
Status
Completed
Phase
Phase 3
Enrollment
194
Locations
1
Results
Not posted
Publications
2
Study summary
What the protocol is testing.
This study is a clinical trial in patients with Parkinson's disease (PD), 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 of nerve cells when tested in the laboratory, which raises the possibility that exenatide may slow down or stop the degeneration of PD. In an open label trial in patients with PD who self administered the drug for a period of 48 weeks, the investigators have previously shown that the drug is well tolerated and shows encouraging effects on the movement and non-movement aspects of the disease. A double blind placebo controlled trial involving 60 participants was then conducted which indicated that exenatide may be a "neuroprotective" drug, i.e. one that stops the nerve cells dying in PD. The next step is therefore to confirm this "neuroprotective" effect and to see whether this effect can be reproduced in a multi-centre setting including a larger number of participants. An important objective is to explore whether any positive effects remain static or increase when the treatment is continued over a 96 week period. In order to explore this, a randomised, double blind, parallel group, placebo controlled, Phase 3 trial of Exenatide is being undertaken (Exenatide-PD3).
Full detailed description
This study is a clinical trial in patients with Parkinson's disease (PD), 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 of nerve cells when tested in the laboratory, which raises the possibility that exenatide may slow down or stop the degeneration of PD. In an open label trial in patients with PD who self administered the drug for a period of 48 weeks, investigators have previously shown that the drug is well tolerated and shows encouraging effects on the movement and non-movement aspects of the disease. A double blind placebo controlled trial involving 60 participants was then conducted which indicated that exenatide may be a "neuroprotective" drug, i.e. one that stops the nerve cells dying in PD. The next step is therefore to confirm this "neuroprotective" effect and to see whether this effect can be reproduced in a multi-centre setting including a larger number of participants. An important objective is to explore whether any positive effects remain static or increase when the treatment is continued over a 96 week period.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Jan 18, 2020
Study start
Jan 20, 2020
Primary completion
Feb 24, 2024
Study completion
Jul 31, 2024
Results posted
Not reported
Registry updated
May 6, 2026
Outcomes
What the study measures.
Primary outcomes
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3
Time frame · 96 weeks
Comparison of MDS-UPDRS part 3 motor sub-score in the practically defined OFF medication state at 96 weeks between participants according to treatment allocation. Min value- 0 Max Value- 108. Higher score indicative of worse outcome.
Secondary outcomes
Movement Disorder Society Unified Parkinson's Disease Rating Scale part 1,2, and 4 ON medication scores.
Time frame · 96 weeks
Questionnaire. Section I: 16 points; Section II: 52; Section IV: 23. Higher score indicative of worse outcome.
Timed Walk assessment ON and OFF medication
Time frame · 96 weeks
Assessment with research team
Montreal Cognitive Assessment
Time frame · 96 weeks
Questionnaire. Maximum Score= 30. Lower scores indicative of worse outcome.
Unified Dyskinesia Rating Scale (UDysRS)
Time frame · 96 weeks
Questionnaire. The UDysRS has four parts: I: Historical Disability (patient perceptions) of On-Dyskinesia impact (maximum 44 points); II: Historical Disability (patient perceptions) of Off-Dystonia impact (maximum 16 points); III: Objective Impairment (dyskinesia severity, anatomical distribution over seven body regions, and type (choreic or dystonic) based on four activities observed or video-recorded (28 points); IV: Objective Disability based on Part III activities (maximum 16 points). Higher scores= worse outcomes
Patient Health Questionnaire-9 (PHQ-9)
Time frame · 96 weeks
Questionnaire. Depression Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. Max Score= 27. Higher Score= worse outcome
Parkinson's Disease 39 item Quality of life questionnaire
Time frame · 96 weeks
This questionnaire assesses how often people affected by Parkinson's experience difficulties across 8 dimensions of daily living. The 39 item questionnaire offers a patient reported measure of health status and quality of life and is the most frequently used disease-specific health status measure. Higher score= worse outcome.
Non-Motor Symptoms Scale (NMSS)
Time frame · 96 weeks
Questionnaire. The Non-Motor Symptoms Scale (NMSS) is a 30-item rater-based scale to assess a wide range of non-motor symptoms in patients with Parkinson's disease (PD). The NMSS measures the severity and frequency of non-motor symptoms across nine dimensions. The scale can be used for patients at all stages of PD. Higher score indicative of worse outcome. NMSS total score is 0 to 360.
Levodopa Equivalent Dose
Time frame · 96 weeks
Assessment with Research Team
3 day Hauser diary of Parkinson's Disease State
Time frame · 96 weeks
Participant take Home questionnaire. (Time-On, Off, Non troublesome Dyskinesia, Troublesome dyskinesia, Asleep). Higher total scores indicate more severe motor signs of Parkinson's.
Safety and tolerability of exenatide as indicated by changes in pulse (bpm)
Time frame · 96 weeks
Vital Signs
Eligibility
Who can take part.
- Minimum age
- 25 Years
- Maximum age
- 80 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: 1. Diagnosis of Parkinson's disease. 2. Hoehn and Yahr stage ≤2.5 in the ON medication state. 3. Between 25 and 80 years of age. 4. On dopaminergic treatment for at least 4 weeks before enrolment. 5. Ability to self-administer, or to arrange carer administration of trial medication. 6. Documented informed consent to participate. Exclusion Criteria: 1. Diagnosis or suspicion of other cause for Parkinsonism. 2. Patients unable to attend the clinic visits in the practically defined OFF medication state. 3. Body mass index \<18.5. 4. Known abnormality on CT or MRI brain imaging considered likely to compromise compliance with trial protocol. 5. Significant cognitive impairment defined by a score \<21 on the Montreal Cognitive Assessment. 6. Concurrent severe depression defined by a score ≥16 on the Patient Health Questionnaire (PHQ-9). 7. Prior intra-cerebral surgical intervention for Parkinson's disease. 8. Previous participation in one of the following Parkinson's disease trials (Biogen SPARK trial, Prothena Pasadena trial, Sanofi Genzyme MOVES-PD trial, UDCA-PD UP Study or any other trial still considered to involve a potentially PD modifying agent). 9. Participation in another clinical trial of a device, drug or surgical treatment within the last 30 days 10. Previous exposure to exenatide. 11. Impaired renal function with creatinine clearance \<50ml/min. 12. History of pancreatitis. 13. Type 1 or Type 2 diabetes mellitus. 14. Severe gastrointestinal disease (e.g. gastroparesis) 15. Hyperlipidaemia. 16. History or family history of medullary thyroid cancer (MTC). 17. Multiple endocrine neoplasia 2 (MEN2) syndrome. 18. Hypersensitivity to any of exenatide's excipients. 19. Females that are pregnant or breast feeding. 20. WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire trial period and up to 3 months after the last dose of trial medication. 21. Participants who lack the capacity to give informed consent 22. Any medical or psychiatric condition or previous conventional/experimental treatment which in the investigator's opinion compromises the potential participant's ability to participate.
Study locations
1 registered sites.
United Kingdom. Showing up to 24 locations stored in the fast local snapshot.
University College London Hospital
London, United Kingdom
Publications
Results and literature.
PMID 39919773 ↗Vijiaratnam N, Girges C, Auld G, McComish R, King A, Skene SS, Hibbert S, Wong A, Melander S, Gibson R, Matthews H, Dickson J, Carroll C, Patrick A, Inches J, Silverdale M, Blackledge B, Whiston J, Hu M, Welch J, Duncan G, Power K, Gallen S, Kerr J, Chaudhuri KR, Batzu L, Rota S, Jabbari E, Morris H, Limousin P, Greig N, Li Y, Libri V, Gandhi S, Athauda D, Chowdhury K, Foltynie T. Exenatide once a week versus placebo as a potential disease-modifying treatment for people with Parkinson's disease in the UK: a phase 3, multicentre, double-blind, parallel-group, randomised, placebo-controlled trial. Lancet. 2025 Feb 22;405(10479):627-636. doi: 10.1016/S0140-6736(24)02808-3. Epub 2025 Feb 4.PMID 34049922 ↗Vijiaratnam N, Girges C, Auld G, Chau M, Maclagan K, King A, Skene S, Chowdhury K, Hibbert S, Morris H, Limousin P, Athauda D, Carroll CB, Hu MT, Silverdale M, Duncan GW, Chaudhuri R, Lo C, Del Din S, Yarnall AJ, Rochester L, Gibson R, Dickson J, Hunter R, Libri V, Foltynie T. Exenatide once weekly over 2 years as a potential disease-modifying treatment for Parkinson's disease: protocol for a multicentre, randomised, double blind, parallel group, placebo controlled, phase 3 trial: The 'Exenatide-PD3' study. BMJ Open. 2021 May 28;11(5):e047993. doi: 10.1136/bmjopen-2020-047993.
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