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Exenatide Once Weekly Over 2 Years as a Potential Disease Modifying Treatment for Parkinson's Disease (Exenatide-PD3)

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ClinicalTrials.gov Identifier: NCT04232969
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
University College, London

Tracking Information
First Submitted Date  ICMJE January 10, 2020
First Posted Date  ICMJE January 18, 2020
Last Update Posted Date April 3, 2020
Actual Study Start Date  ICMJE January 20, 2020
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2020)
  • 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
  • Safety and tolerability of exenatide as indicated by changes in blood pressure (mmHg) [ Time Frame: 96 weeks ]
    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) [ Time Frame: 96 weeks ]
    Vital Signs
  • Safety and tolerability of exenatide as indicated by changes in Red Blood Cell Count (10^12/L) [ Time Frame: 96 weeks ]
    Full Blood Count
  • Safety and tolerability of exenatide as indicated by changes in White Blood Cell Count (10^9/L) [ Time Frame: 96 weeks ]
    Full Blood Count
  • Safety and tolerability of exenatide as indicated by changes in Haemoglobin (g/dL) [ Time Frame: 96 weeks ]
    Full Blood Count
  • Safety and tolerability of exenatide as indicated by changes in Haematocrit (%) [ Time Frame: 96 weeks ]
    Full Blood Count
  • Safety and tolerability of exenatide as indicated by changes in Platelets (10^9/L) [ Time Frame: 96 weeks ]
    Full Blood Count
  • Safety and tolerability of exenatide as indicated by changes in Neutrophils (10^9/L) [ Time Frame: 96 weeks ]
    Full Blood Count
  • Safety and tolerability of exenatide as indicated by changes in Eosinophils (10^9/L) [ Time Frame: 96 weeks ]
    Full Blood Count
  • Safety and tolerability of exenatide as indicated by changes in Basophils (10^9/L) [ Time Frame: 96 weeks ]
    Full Blood Count
  • Safety and tolerability of exenatide as indicated by changes in Lymphocytes (10^9/L) [ Time Frame: 96 weeks ]
    Full Blood Count
  • Safety and tolerability of exenatide as indicated by changes in Monocytes (10^9/L) [ Time Frame: 96 weeks ]
    Full Blood Count
  • Safety and tolerability of exenatide as indicated by changes in Prothrombin Time (secs) [ Time Frame: 96 weeks ]
    Blood Tests (Coagulation)
  • Safety and tolerability of exenatide as indicated by changes in International Normalized Ratio (Calculated from Prothrombin Time) [ Time Frame: 96 weeks ]
    Blood Tests (Coagulation)
  • Safety and tolerability of exenatide as indicated by changes in Activated Partial Thromboplastin Time (secs) [ Time Frame: 96 weeks ]
    Blood Tests (Coagulation)
  • Safety and tolerability of exenatide as indicated by changes in Thrombin Time (secs) [ Time Frame: 96 weeks ]
    Blood Tests (Coagulation)
  • Safety and tolerability of exenatide as indicated by changes in Fibrinogen (g/L) [ Time Frame: 96 weeks ]
    Blood Tests (Coagulation)
  • Safety and tolerability of exenatide as indicated by changes in Glycated Haemoglobin (% of Haemoglobin) [ Time Frame: 96 weeks ]
    Blood Tests (Blood Sugar Levels / Diabetes Testing)
  • Safety and tolerability of exenatide as indicated by changes in Sodium (mmol/L) [ Time Frame: 96 weeks ]
    Biochemistry
  • Safety and tolerability of exenatide as indicated by changes in Potassium (mmol/L) [ Time Frame: 96 weeks ]
    Biochemistry
  • Safety and tolerability of exenatide as indicated by changes in Urea (mmol/L) [ Time Frame: 96 weeks ]
    Biochemistry
  • Safety and tolerability of exenatide as indicated by changes in Creatinine (µmol/L) [ Time Frame: 96 weeks ]
    Biochemistry
  • Safety and tolerability of exenatide as indicated by changes in Creatinine Clearance (ml/min) [ Time Frame: 96 weeks ]
    Biochemistry
  • Safety and tolerability of exenatide as indicated by changes in Total Bilirubin (µmol/L) [ Time Frame: 96 weeks ]
    Biochemistry
  • Safety and tolerability of exenatide as indicated by changes in Alkaline phosphatase (IU/L) [ Time Frame: 96 weeks ]
    Biochemistry
  • Safety and tolerability of exenatide as indicated by changes in Alanine transaminase (IU/L) [ Time Frame: 96 weeks ]
    Biochemistry
  • Safety and tolerability of exenatide as indicated by changes in Aspartate Aminotransferase (IU/L) [ Time Frame: 96 weeks ]
    Biochemistry
  • Safety and tolerability of exenatide as indicated by changes in Serum Amylase (U/L) [ Time Frame: 96 weeks ]
    Biochemistry
  • Safety and tolerability of exenatide as indicated by changes in Thyroid Stimulating Hormone (mIU/L) [ Time Frame: 96 weeks ]
    Biochemistry
  • Safety and tolerability of exenatide as indicated by changes in Thyroxin (T4) (pmol/L) [ Time Frame: 96 weeks ]
    Biochemistry
  • Safety and tolerability of exenatide as indicated by changes in Triglycerides (mg/dL) [ Time Frame: 96 weeks ]
    Biochemistry (Fasting)
  • Safety and tolerability of exenatide as indicated by changes in Cholesterol (mg/dL) [ Time Frame: 96 weeks ]
    Biochemistry (Fasting)
  • Safety and tolerability of exenatide as indicated by changes in Glucose (mmol/L) [ Time Frame: 96 weeks ]
    Biochemistry (Fasting)
  • Safety and tolerability of exenatide as indicated by changes in Insulin (IU/L) [ Time Frame: 96 weeks ]
    Biochemistry (Fasting)
  • Safety and tolerability of exenatide as indicated by the occurrence / severity of Adverse Events [ Time Frame: 96 weeks ]
    Ongoing Safety Reporting
Original Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2020)
  • Movement Disorder Society Unified Parkinson's Disease Rating Scale part 1,2, and 4 ON medication scores. Section I: 16 points; Section II: 52; Section IV: 23. Higher score indicative of worse outcome [ Time Frame: 96 weeks ]
    Questionnaire
  • 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.
  • 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)
  • Safety and tolerability of exenatide as indicated by changes in pulse (bpm) [ Time Frame: 96 weeks ]
    Vital Signs
  • Safety and tolerability of exenatide as indicated by changes in blood pressure (mmHg) [ Time Frame: 96 weeks ]
    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) [ Time Frame: 96 weeks ]
    Vital Signs
  • Safety and tolerability of exenatide as indicated by changes in Red Blood Cell Count (10^12/L) [ Time Frame: 96 weeks ]
    Full Blood Count
  • Safety and tolerability of exenatide as indicated by changes in White Blood Cell Count (10^9/L) [ Time Frame: 96 weeks ]
    Full Blood Count
  • Safety and tolerability of exenatide as indicated by changes in Haemoglobin (g/dL) [ Time Frame: 96 weeks ]
    Full Blood Count
  • Safety and tolerability of exenatide as indicated by changes in Haematocrit (%) [ Time Frame: 96 weeks ]
    Full Blood Count
  • Safety and tolerability of exenatide as indicated by changes in Platelets (10^9/L) [ Time Frame: 96 weeks ]
    Full Blood Count
  • Safety and tolerability of exenatide as indicated by changes in Neutrophils (10^9/L) [ Time Frame: 96 weeks ]
    Full Blood Count
  • Safety and tolerability of exenatide as indicated by changes in Eosinophils (10^9/L) [ Time Frame: 96 weeks ]
    Full Blood Count
  • Safety and tolerability of exenatide as indicated by changes in Basophils (10^9/L) [ Time Frame: 96 weeks ]
    Full Blood Count
  • Safety and tolerability of exenatide as indicated by changes in Lymphocytes (10^9/L) [ Time Frame: 96 weeks ]
    Full Blood Count
  • Safety and tolerability of exenatide as indicated by changes in Monocytes (10^9/L) [ Time Frame: 96 weeks ]
    Full Blood Count
  • Safety and tolerability of exenatide as indicated by changes in Prothrombin Time (secs) [ Time Frame: 96 weeks ]
    Blood Tests (Coagulation)
  • Safety and tolerability of exenatide as indicated by changes in International Normalized Ratio (Calculated from Prothrombin Time) [ Time Frame: 96 weeks ]
    Blood Tests (Coagulation)
  • Safety and tolerability of exenatide as indicated by changes in Activated Partial Thromboplastin Time (secs) [ Time Frame: 96 weeks ]
    Blood Tests (Coagulation)
  • Safety and tolerability of exenatide as indicated by changes in Thrombin Time (secs) [ Time Frame: 96 weeks ]
    Blood Tests (Coagulation)
  • Safety and tolerability of exenatide as indicated by changes in Fibrinogen (g/L) [ Time Frame: 96 weeks ]
    Blood Tests (Coagulation)
  • Safety and tolerability of exenatide as indicated by changes in Glycated Haemoglobin (% of Haemoglobin) [ Time Frame: 96 weeks ]
    Blood Tests (Blood Sugar Levels / Diabetes Testing)
  • Safety and tolerability of exenatide as indicated by changes in Sodium (mmol/L) [ Time Frame: 96 weeks ]
    Biochemistry
  • Safety and tolerability of exenatide as indicated by changes in Potassium (mmol/L) [ Time Frame: 96 weeks ]
    Biochemistry
  • Safety and tolerability of exenatide as indicated by changes in Urea (mmol/L) [ Time Frame: 96 weeks ]
    Biochemistry
  • Safety and tolerability of exenatide as indicated by changes in Creatinine (µmol/L) [ Time Frame: 96 weeks ]
    Biochemistry
  • Safety and tolerability of exenatide as indicated by changes in Creatinine Clearance (ml/min) [ Time Frame: 96 weeks ]
    Biochemistry
  • Safety and tolerability of exenatide as indicated by changes in Total Bilirubin (µmol/L) [ Time Frame: 96 weeks ]
    Biochemistry
  • Safety and tolerability of exenatide as indicated by changes in Alkaline phosphatase (IU/L) [ Time Frame: 96 weeks ]
    Biochemistry
  • Safety and tolerability of exenatide as indicated by changes in Alanine transaminase (IU/L) [ Time Frame: 96 weeks ]
    Biochemistry
  • Safety and tolerability of exenatide as indicated by changes in Aspartate Aminotransferase (IU/L) [ Time Frame: 96 weeks ]
    Biochemistry
  • Safety and tolerability of exenatide as indicated by changes in Serum Amylase (U/L) [ Time Frame: 96 weeks ]
    Biochemistry
  • Safety and tolerability of exenatide as indicated by changes in Thyroid Stimulating Hormone (mIU/L) [ Time Frame: 96 weeks ]
    Biochemistry
  • Safety and tolerability of exenatide as indicated by changes in Thyroxin (T4) (pmol/L) [ Time Frame: 96 weeks ]
    Biochemistry
  • Safety and tolerability of exenatide as indicated by changes in Triglycerides (mg/dL) [ Time Frame: 96 weeks ]
    Biochemistry (Fasting)
  • Safety and tolerability of exenatide as indicated by changes in Cholesterol (mg/dL) [ Time Frame: 96 weeks ]
    Biochemistry (Fasting)
  • Safety and tolerability of exenatide as indicated by changes in Glucose (mmol/L) [ Time Frame: 96 weeks ]
    Biochemistry (Fasting)
  • Safety and tolerability of exenatide as indicated by changes in Insulin (IU/L) [ Time Frame: 96 weeks ]
    Biochemistry (Fasting)
  • Safety and tolerability of exenatide as indicated by the occurrence / severity of Adverse Events [ Time Frame: 96 weeks ]
    Ongoing Safety Reporting
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exenatide Once Weekly Over 2 Years as a Potential Disease Modifying Treatment for Parkinson's Disease
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double Blind
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE Drug: Exenatide extended release 2mg (Bydureon)
Subcutaneous Injection
Study Arms  ICMJE
  • Active Comparator: Exenatide
    Exenatide extended release 2mg (Bydureon) once weekly for 96 weeks n=100
    Intervention: Drug: Exenatide extended release 2mg (Bydureon)
  • Placebo Comparator: Placebo
    Exenatide extended release placebo once weekly for 96 weeks n=100
    Intervention: Drug: Exenatide extended release 2mg (Bydureon)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 16, 2020)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2023
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Professor Tom Foltynie 020 3448 8726 t.foltynie@ucl.ac.uk
Contact: Grace Auld 02076799895 g.auld@ucl.ac.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04232969
Other Study ID Numbers  ICMJE 18/0320
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University College, London
Study Sponsor  ICMJE University College, London
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tom Foltynie University College London Comprehensive Clinical Trials Unit
PRS Account University College, London
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP