Back to resultsExenatide Once Weekly Over 2 Years as a Potential Disease Modifying Treatment for Parkinson's Disease (Exenatide-PD3)
Primary Purpose
Parkinson's Disease
Status
Active
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Exenatide extended release 2mg (Bydureon)
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's Disease, Exenatide, Parkinson's research
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Parkinson's disease.
- Hoehn and Yahr stage ≤2.5 in the ON medication state.
- Between 25 and 80 years of age.
- On dopaminergic treatment for at least 4 weeks before enrolment.
- Ability to self-administer, or to arrange carer administration of trial medication.
- Documented informed consent to participate.
Exclusion Criteria:
- Diagnosis or suspicion of other cause for Parkinsonism.
- Patients unable to attend the clinic visits in the practically defined OFF medication state.
- Body mass index <18.5.
- Known abnormality on CT or MRI brain imaging considered likely to compromise compliance with trial protocol.
- Significant cognitive impairment defined by a score <21 on the Montreal Cognitive Assessment.
- Concurrent severe depression defined by a score ≥16 on the Patient Health Questionnaire (PHQ-9).
- Prior intra-cerebral surgical intervention for Parkinson's disease.
- 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).
- Participation in another clinical trial of a device, drug or surgical treatment within the last 30 days
- Previous exposure to exenatide.
- Impaired renal function with creatinine clearance <50ml/min.
- History of pancreatitis.
- Type 1 or Type 2 diabetes mellitus.
- Severe gastrointestinal disease (e.g. gastroparesis)
- Hyperlipidaemia.
- History or family history of medullary thyroid cancer (MTC).
- Multiple endocrine neoplasia 2 (MEN2) syndrome.
- Hypersensitivity to any of exenatide's excipients.
- Females that are pregnant or breast feeding.
- 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.
- Participants who lack the capacity to give informed consent
- Any medical or psychiatric condition or previous conventional/experimental treatment which in the investigator's opinion compromises the potential participant's ability to participate.
Sites / Locations
- University College London Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Exenatide
Placebo
Arm Description
Exenatide extended release 2mg (Bydureon) once weekly for 96 weeks n=100
Exenatide extended release placebo once weekly for 96 weeks n=100
Outcomes
Primary Outcome Measures
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3
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 Outcome Measures
Movement Disorder Society Unified Parkinson's Disease Rating Scale part 1,2, and 4 ON medication scores.
Questionnaire. Section I: 16 points; Section II: 52; Section IV: 23. Higher score indicative of worse outcome.
Timed Walk assessment ON and OFF medication
Assessment with research team
Montreal Cognitive Assessment
Questionnaire. Maximum Score= 30. Lower scores indicative of worse outcome.
Unified Dyskinesia Rating Scale (UDysRS)
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)
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
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)
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
Assessment with Research Team
3 day Hauser diary of Parkinson's Disease State
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)
Vital Signs
Safety and tolerability of exenatide as indicated by changes in blood pressure (mmHg)
Vital Signs
Safety and tolerability of exenatide as indicated by changes in Body Mass Index (weight and height will be combined to report BMI in kg/m^2)
Vital Signs
Safety and tolerability of exenatide as indicated by changes in Red Blood Cell Count (10^12/L)
Full Blood Count
Safety and tolerability of exenatide as indicated by changes in White Blood Cell Count (10^9/L)
Full Blood Count
Safety and tolerability of exenatide as indicated by changes in Haemoglobin (g/dL)
Full Blood Count
Safety and tolerability of exenatide as indicated by changes in Haematocrit (%)
Full Blood Count
Safety and tolerability of exenatide as indicated by changes in Platelets (10^9/L)
Full Blood Count
Safety and tolerability of exenatide as indicated by changes in Neutrophils (10^9/L)
Full Blood Count
Safety and tolerability of exenatide as indicated by changes in Eosinophils (10^9/L)
Full Blood Count
Safety and tolerability of exenatide as indicated by changes in Basophils (10^9/L)
Full Blood Count
Safety and tolerability of exenatide as indicated by changes in Lymphocytes (10^9/L)
Full Blood Count
Safety and tolerability of exenatide as indicated by changes in Monocytes (10^9/L)
Full Blood Count
Safety and tolerability of exenatide as indicated by changes in Prothrombin Time (secs)
Blood Tests (Coagulation)
Safety and tolerability of exenatide as indicated by changes in International Normalized Ratio (Calculated from Prothrombin Time)
Blood Tests (Coagulation)
Safety and tolerability of exenatide as indicated by changes in Activated Partial Thromboplastin Time (secs)
Blood Tests (Coagulation)
Safety and tolerability of exenatide as indicated by changes in Thrombin Time (secs)
Blood Tests (Coagulation)
Safety and tolerability of exenatide as indicated by changes in Fibrinogen (g/L)
Blood Tests (Coagulation)
Safety and tolerability of exenatide as indicated by changes in Glycated Haemoglobin (% of Haemoglobin)
Blood Tests (Blood Sugar Levels / Diabetes Testing)
Safety and tolerability of exenatide as indicated by changes in Sodium (mmol/L)
Biochemistry
Safety and tolerability of exenatide as indicated by changes in Potassium (mmol/L)
Biochemistry
Safety and tolerability of exenatide as indicated by changes in Urea (mmol/L)
Biochemistry
Safety and tolerability of exenatide as indicated by changes in Creatinine (µmol/L)
Biochemistry
Safety and tolerability of exenatide as indicated by changes in Creatinine Clearance (ml/min)
Biochemistry
Safety and tolerability of exenatide as indicated by changes in Total Bilirubin (µmol/L)
Biochemistry
Safety and tolerability of exenatide as indicated by changes in Alkaline phosphatase (IU/L)
Biochemistry
Safety and tolerability of exenatide as indicated by changes in Alanine transaminase (IU/L)
Biochemistry
Safety and tolerability of exenatide as indicated by changes in Aspartate Aminotransferase (IU/L)
Biochemistry
Safety and tolerability of exenatide as indicated by changes in Serum Amylase (U/L)
Biochemistry
Safety and tolerability of exenatide as indicated by changes in Thyroid Stimulating Hormone (mIU/L)
Biochemistry
Safety and tolerability of exenatide as indicated by changes in Thyroxin (T4) (pmol/L)
Biochemistry
Safety and tolerability of exenatide as indicated by changes in Triglycerides (mg/dL)
Biochemistry (Fasting)
Safety and tolerability of exenatide as indicated by changes in Cholesterol (mg/dL)
Biochemistry (Fasting)
Safety and tolerability of exenatide as indicated by changes in Glucose (mmol/L)
Biochemistry (Fasting)
Safety and tolerability of exenatide as indicated by changes in Insulin (IU/L)
Biochemistry (Fasting)
Safety and tolerability of exenatide as indicated by the occurrence / severity of Adverse Events
Ongoing Safety Reporting
Full Information
NCT ID
NCT04232969
First Posted
January 10, 2020
Last Updated
May 18, 2022
Sponsor
University College, London
1. Study Identification
Unique Protocol Identification Number
NCT04232969
Brief Title
Exenatide Once Weekly Over 2 Years as a Potential Disease Modifying Treatment for Parkinson's Disease
Acronym
Exenatide-PD3
Official Title
A Randomised, Double Blind, Parallel Group, Placebo Controlled, Phase 3 Trial of Exenatide Once Weekly Over 2 Years as a Potential Disease Modifying Treatment for Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 20, 2020 (Actual)
Primary Completion Date
February 24, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's Disease, Exenatide, Parkinson's research
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
A randomised, double blind, parallel group, placebo controlled, Phase 3 trial of Exenatide once weekly over 2 years as a potential disease modifying treatment for Parkinson's disease.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double Blind
Allocation
Randomized
Enrollment
194 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exenatide
Arm Type
Active Comparator
Arm Description
Exenatide extended release 2mg (Bydureon) once weekly for 96 weeks n=100
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Exenatide extended release placebo once weekly for 96 weeks n=100
Intervention Type
Drug
Intervention Name(s)
Exenatide extended release 2mg (Bydureon)
Intervention Description
Subcutaneous Injection
Primary Outcome Measure Information:
Title
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3
Description
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.
Time Frame
96 weeks
Secondary Outcome Measure Information:
Title
Movement Disorder Society Unified Parkinson's Disease Rating Scale part 1,2, and 4 ON medication scores.
Description
Questionnaire. Section I: 16 points; Section II: 52; Section IV: 23. Higher score indicative of worse outcome.
Time Frame
96 weeks
Title
Timed Walk assessment ON and OFF medication
Description
Assessment with research team
Time Frame
96 weeks
Title
Montreal Cognitive Assessment
Description
Questionnaire. Maximum Score= 30. Lower scores indicative of worse outcome.
Time Frame
96 weeks
Title
Unified Dyskinesia Rating Scale (UDysRS)
Description
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
Time Frame
96 weeks
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
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
Time Frame
96 weeks
Title
Parkinson's Disease 39 item Quality of life questionnaire
Description
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.
Time Frame
96 weeks
Title
Non-Motor Symptoms Scale (NMSS)
Description
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.
Time Frame
96 weeks
Title
Levodopa Equivalent Dose
Description
Assessment with Research Team
Time Frame
96 weeks
Title
3 day Hauser diary of Parkinson's Disease State
Description
Participant take Home questionnaire. (Time-On, Off, Non troublesome Dyskinesia, Troublesome dyskinesia, Asleep). Higher total scores indicate more severe motor signs of Parkinson's.
Time Frame
96 weeks
Title
Safety and tolerability of exenatide as indicated by changes in pulse (bpm)
Description
Vital Signs
Time Frame
96 weeks
Title
Safety and tolerability of exenatide as indicated by changes in blood pressure (mmHg)
Description
Vital Signs
Time Frame
96 weeks
Title
Safety and tolerability of exenatide as indicated by changes in Body Mass Index (weight and height will be combined to report BMI in kg/m^2)
Description
Vital Signs
Time Frame
96 weeks
Title
Safety and tolerability of exenatide as indicated by changes in Red Blood Cell Count (10^12/L)
Description
Full Blood Count
Time Frame
96 weeks
Title
Safety and tolerability of exenatide as indicated by changes in White Blood Cell Count (10^9/L)
Description
Full Blood Count
Time Frame
96 weeks
Title
Safety and tolerability of exenatide as indicated by changes in Haemoglobin (g/dL)
Description
Full Blood Count
Time Frame
96 weeks
Title
Safety and tolerability of exenatide as indicated by changes in Haematocrit (%)
Description
Full Blood Count
Time Frame
96 weeks
Title
Safety and tolerability of exenatide as indicated by changes in Platelets (10^9/L)
Description
Full Blood Count
Time Frame
96 weeks
Title
Safety and tolerability of exenatide as indicated by changes in Neutrophils (10^9/L)
Description
Full Blood Count
Time Frame
96 weeks
Title
Safety and tolerability of exenatide as indicated by changes in Eosinophils (10^9/L)
Description
Full Blood Count
Time Frame
96 weeks
Title
Safety and tolerability of exenatide as indicated by changes in Basophils (10^9/L)
Description
Full Blood Count
Time Frame
96 weeks
Title
Safety and tolerability of exenatide as indicated by changes in Lymphocytes (10^9/L)
Description
Full Blood Count
Time Frame
96 weeks
Title
Safety and tolerability of exenatide as indicated by changes in Monocytes (10^9/L)
Description
Full Blood Count
Time Frame
96 weeks
Title
Safety and tolerability of exenatide as indicated by changes in Prothrombin Time (secs)
Description
Blood Tests (Coagulation)
Time Frame
96 weeks
Title
Safety and tolerability of exenatide as indicated by changes in International Normalized Ratio (Calculated from Prothrombin Time)
Description
Blood Tests (Coagulation)
Time Frame
96 weeks
Title
Safety and tolerability of exenatide as indicated by changes in Activated Partial Thromboplastin Time (secs)
Description
Blood Tests (Coagulation)
Time Frame
96 weeks
Title
Safety and tolerability of exenatide as indicated by changes in Thrombin Time (secs)
Description
Blood Tests (Coagulation)
Time Frame
96 weeks
Title
Safety and tolerability of exenatide as indicated by changes in Fibrinogen (g/L)
Description
Blood Tests (Coagulation)
Time Frame
96 weeks
Title
Safety and tolerability of exenatide as indicated by changes in Glycated Haemoglobin (% of Haemoglobin)
Description
Blood Tests (Blood Sugar Levels / Diabetes Testing)
Time Frame
96 weeks
Title
Safety and tolerability of exenatide as indicated by changes in Sodium (mmol/L)
Description
Biochemistry
Time Frame
96 weeks
Title
Safety and tolerability of exenatide as indicated by changes in Potassium (mmol/L)
Description
Biochemistry
Time Frame
96 weeks
Title
Safety and tolerability of exenatide as indicated by changes in Urea (mmol/L)
Description
Biochemistry
Time Frame
96 weeks
Title
Safety and tolerability of exenatide as indicated by changes in Creatinine (µmol/L)
Description
Biochemistry
Time Frame
96 weeks
Title
Safety and tolerability of exenatide as indicated by changes in Creatinine Clearance (ml/min)
Description
Biochemistry
Time Frame
96 weeks
Title
Safety and tolerability of exenatide as indicated by changes in Total Bilirubin (µmol/L)
Description
Biochemistry
Time Frame
96 weeks
Title
Safety and tolerability of exenatide as indicated by changes in Alkaline phosphatase (IU/L)
Description
Biochemistry
Time Frame
96 weeks
Title
Safety and tolerability of exenatide as indicated by changes in Alanine transaminase (IU/L)
Description
Biochemistry
Time Frame
96 weeks
Title
Safety and tolerability of exenatide as indicated by changes in Aspartate Aminotransferase (IU/L)
Description
Biochemistry
Time Frame
96 weeks
Title
Safety and tolerability of exenatide as indicated by changes in Serum Amylase (U/L)
Description
Biochemistry
Time Frame
96 weeks
Title
Safety and tolerability of exenatide as indicated by changes in Thyroid Stimulating Hormone (mIU/L)
Description
Biochemistry
Time Frame
96 weeks
Title
Safety and tolerability of exenatide as indicated by changes in Thyroxin (T4) (pmol/L)
Description
Biochemistry
Time Frame
96 weeks
Title
Safety and tolerability of exenatide as indicated by changes in Triglycerides (mg/dL)
Description
Biochemistry (Fasting)
Time Frame
96 weeks
Title
Safety and tolerability of exenatide as indicated by changes in Cholesterol (mg/dL)
Description
Biochemistry (Fasting)
Time Frame
96 weeks
Title
Safety and tolerability of exenatide as indicated by changes in Glucose (mmol/L)
Description
Biochemistry (Fasting)
Time Frame
96 weeks
Title
Safety and tolerability of exenatide as indicated by changes in Insulin (IU/L)
Description
Biochemistry (Fasting)
Time Frame
96 weeks
Title
Safety and tolerability of exenatide as indicated by the occurrence / severity of Adverse Events
Description
Ongoing Safety Reporting
Time Frame
96 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Parkinson's disease.
Hoehn and Yahr stage ≤2.5 in the ON medication state.
Between 25 and 80 years of age.
On dopaminergic treatment for at least 4 weeks before enrolment.
Ability to self-administer, or to arrange carer administration of trial medication.
Documented informed consent to participate.
Exclusion Criteria:
Diagnosis or suspicion of other cause for Parkinsonism.
Patients unable to attend the clinic visits in the practically defined OFF medication state.
Body mass index <18.5.
Known abnormality on CT or MRI brain imaging considered likely to compromise compliance with trial protocol.
Significant cognitive impairment defined by a score <21 on the Montreal Cognitive Assessment.
Concurrent severe depression defined by a score ≥16 on the Patient Health Questionnaire (PHQ-9).
Prior intra-cerebral surgical intervention for Parkinson's disease.
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).
Participation in another clinical trial of a device, drug or surgical treatment within the last 30 days
Previous exposure to exenatide.
Impaired renal function with creatinine clearance <50ml/min.
History of pancreatitis.
Type 1 or Type 2 diabetes mellitus.
Severe gastrointestinal disease (e.g. gastroparesis)
Hyperlipidaemia.
History or family history of medullary thyroid cancer (MTC).
Multiple endocrine neoplasia 2 (MEN2) syndrome.
Hypersensitivity to any of exenatide's excipients.
Females that are pregnant or breast feeding.
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.
Participants who lack the capacity to give informed consent
Any medical or psychiatric condition or previous conventional/experimental treatment which in the investigator's opinion compromises the potential participant's ability to participate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Foltynie
Organizational Affiliation
University College London Comprehensive Clinical Trials Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
University College London Hospital
City
London
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34049922
Citation
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.
Results Reference
derived
Links:
URL
https://www.ucl.ac.uk/comprehensive-clinical-trials-unit/research-projects/2021/jan/exenatide-parkinsons-disease
Description
Sponsor Trial web link
Learn more about this trial
Exenatide Once Weekly Over 2 Years as a Potential Disease Modifying Treatment for Parkinson's Disease
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