A trial comparing simvastatin to placebo as a neuronal protective treatment for Parkinson's disease.

Phase 1

• Conditions: Parkinson's disease; MedDRA version: 18.0Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 18.0Level: LLTClassification code 10013113Term: Disease Parkinson'sSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-000148-40-GB
• Lead Sponsor: Plymouth Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-16
• Last Update Posted: 19 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

• Diagnosis of idiopathic PD
• Modified Hoehn and Yahr stage = 3.0 in the ON medication state
• Age 40-90 years
• On dopaminergic treatment with wearing-off phenomenon
• Able to comply with study protocol and willing to attend necessary study visits
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 48

Exclusion Criteria

•Diagnosis or suspicion of other cause for parkinsonism
•Known abnormality on CT or MRI brain imaging considered to be causing symptoms or signs of neurological dysfunction, or considered likely to compromise compliance with study protocol
•Concurrent dementia defined by MoCA score <21
•Concurrent severe depression defined by MADRS score >31
•Prior intracerebral surgical intervention for PD including deep brain stimulation, lesional surgery, growth factor administration, gene therapy or cell transplantation
•Already actively participating in a research study that might conflict with this trial
•Prior or current use of statins as a lipid lowering therapy
•Intolerance to statins
•Untreated hypothyroidism
•End stage renal disease (creatinine clearance <30 mL/min) or history of severe cardiac disease (angina, myocardial infarction or cardiac surgery in preceding two years)
•eGFR <30 mL/min
• History of alcoholism or liver impairment
•Creatine kinase (CK) >1.1 x upper limit of normal (ULN)
•Aspartate transaminase (AST) or alanine transaminase (ALT) >1.1 x ULN
•Females who are pregnant or breast feeding or of child-bearing potential and unwilling to use appropriate contraception methods whilst on trial treatment
•Currently taking any medication contraindicated with simvastatin use
•Any requirement for statin use
•Regular participation in endurance or high-impact sports
•Unable to abstain from consumption of grapefruit-based products

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether simvastatin is clearly ineffective (futile) in preventing the clinical decline of PD as measured by the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) motor score. ;Secondary Objective: To confirm the safety and tolerability of simvastatin in patients with PD.<br>To distinguish symptomatic effects of simvastatin from disease modifying effects. <br>To evaluate the impact of simvastatin on activities of daily living (ADL), timed motor tests, cognitive ability, mood, behaviour, non-motor symptoms (NMS) and quality of life among patients with moderate PD using standard validated tools of assessment. ;Primary end point(s): A change in MDS-UPDRS (Movement Disorder Society Unified Parkinson's disease Rating Scale) part III motor subscale score in the OFF state over 24 months.;Timepoint(s) of evaluation of this end point: 24 months.