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Proposal 1142

Title of the Proposed Research

A meta-analysis of Parkinson’s disease

Lead Researcher

Atul Butte

Affiliation

Division of Systems Medicine
Department of Pediatrics
Stanford University

Funding Source

None

Potential Conflicts of Interest

None

Data Sharing Agreement Date

19 August 2015

Lay Summary

One common thread to many of the poorly understood illnesses is their complexity. Diseases such as Parkinson’s Disease (PD) usually involve several genetic and environmental factors, not all of which are known. This complexity and the involvement of many factors make investigating such diseases even more difficult. However, by integrating information from several different sources, a better and clearer understanding could be achieved.

The availability of clinical data from different trials makes such data an attractive source for systemic research and meta-analysis. Examining disease-related patterns by meta-analysis can help gain better insight into disease-related characteristics and assist in finding new discoveries and insights. Moreover, by combining data from multiple clinical studies evaluating Parkinson’s disease with various outcome measures might help to leverage the improvement in efficacy by possible combination of treatments.

In this study we propose the meta-analysis of PD related data collected and combined from several clinical studies evaluating three different treatments for PD.

Study Data Provided

Study BI-248.524: Efficacy, Safety, Tolerability of Pramipexole ER Versus Pramipexol IR Versus Placebo in Early PD Patients
Study BI-248.596: Pramipexole Versus Placebo in Parkinson's Disease (PD) Patients With Depressive Symptoms
Study BI-248.622: A Randomized, Double-blind, Active (Pramipexole 0.5 mg Tid) and Placebo Controlled, Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over 12-week Treatment in Early Parkinson's Disease (PD) Patients
Study BI-248.633: Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson's Disease (PD)
Study BI-248.634: Long-term Safety Study of Open-label Pramipexole ER in Patients With Advanced PD
Study BI-248.636: Overnight Switch Trial From Pramipexole IR to Pramipexole ER in Patients With Early Parkinson Disease
Study BI-248.525: Pivotal Study in Advanced Parkinson Disease Patients
Study BI-248.595: Study of (Mirapex) Pramipexole for the Early Treatment of Parkinson Disease (PD)
Study BI-248.610: A 12-week Study of Pramipexole ER in Patients With Parkinson's Disease, Followed by a 52-week Long-term Treatment Period
Study BI-248.544: Safety, Tolerability and Efficacy of Switching From Talipexole to Pramipexole in Patients With Parkinson's Disease
Study GSK-ROP109087: An open label, repeat dose, dose escalation study conducted in Parkinson's Disease patients to characterize the pharmacokinetics and effect of food on ropinirole prolonged release (PR/CR) 12mg tablets.
Study GSK-ROP112771: An open label study conducted in healthy subjects to demonstrate bioequivalence between ropinirole prolonged release tablets (ropinirole XL, marketed as REQUIP-MODUTAB™, REQUIP XL™ at 2 mg) manufactured at Crawley and Aranda
Study GSK-101468/165: An open-label, up-titration study to assess the dose proportionality of ropinirole controlled release (CR) and to demonstrate the bioequivalence of ropinirole CR (1 x 8 mg) compared to the ropinirole CR (4 x 2 mg) in Parkinson's Disease patients not receiving other dopaminergic therapies.
Study GSK-SKF-101468/166: A Phase II, randomised, double-blind, active-controlled, dose-escalation study to determine the maximum well-tolerated starting dose of a new formulation of ropinirole in Parkinson's Disease patients not receiving other dopaminergic therapies
Study GSK-101468/168: A Randomised, Double Blind, Three Period, Cross-Over Study of Ropinirole CR and Ropinirole IR Monotherapy
Study GSK-101468/169: A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment with Ropinirole CR as Adjunctive Therapy in Patients with Parkinson's Disease who are not Optimally Controlled on L-dopa
Study GSK-101468/196: 101468/196: A Long-Term, Open-Label Continuation Study of Once Daily Administration of Ropinirole CR Tablets to Patients with Parkinson's Disease who Completed the Previous Ropinirole CR Studies 167 or 164
Study GSK-101468/219: An open label, randomised, five-way crossover single-dose pharmacokinetic study to assess dosage strength equivalence of ropinirole CR in healthy male and female volunteers
Study GSK-101468/228: A two year Phase IIIb randomised, multicenter, double-blind, SINEMET controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects.
Study GSK-SKF-101468/125: A double-blind, multicentre, flexible dose, L-dopa controlled study of ropinirole to investigate A) neuroprotective effect as measured by 3D PET scanning, and B) ophthalmological safety, in patients with early Parkinson’s disease
Study UCB-SP506: A multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to assess the efficacy, safety, and tolerability of escalating transdermal doses of rotigotine (SPM 962) in subjects with early-stage Parkinson’s disease
Study UCB-SP512: A multi-center, multinational, phase III, randomized, double-blind, placebocontrolled trial, of the efficacy and safety of the rotigotine patch in subjects with earlystage, idiopathic Parkinson's disease
Study UCB-SP513: A multi-center, multinational, phase III, randomized, double-blind, doubledummy, 3-arm parallel group, placebo- and ropinirole-controlled trial of the efficacy and safety of the rotigotine CDS patch in subjects with early-stage idiopathic Parkinson?s disease
Study UCB-SP650: A multi-center, multinational, Phase 3, randomized, double-blind, parallel group, placebo-controlled trial of the efficacy and safety of rotigotine CDS patch (2 target doses) in subjects with advanced-stage, idiopathic Parkinson?s disease who are not well controlled on levodopa
Study UCB-SP515: Rotigotine Patch in Subjects With Advanced Stage, Idiopathic Parkinson's Disease Who Are Not Well Controlled on Levodopa

Statistical Analysis Plan

The statistical analysis plan will be added after the research is published.

Publication Citation

The publication citation will be added after the research is published.