This project will provide Coordination, Data Management and Statistical support for the conduct of a clinical trial of Coenzyme Q10 in early Parkinson's disease to be led by Dr. Flint Beat, the PI of a companion grant, 'Effects of Coenzyme Q10 in Early Parkinson's Disease - Phase 3"""""""" submitted by Weill Medical College, Cornell University (Weill). The trial will attempt to confirm & further explore a previously noted effect of Coenzyme Q10 (CoQ10) in patients with early Parkinson's disease.
Specific aims of this application are:1) To develop a randomization algorithm for assigning subjects to the different treatments, to implement this as part of a password-protected EDC data-entry system, which will automatically check inclusion criteria, generate visit windows, & requests for packaging of study medication. To maintain a blindedness policy to ensure that treatment assignments are concealed from central coordination & data management staff, study investigators, coordinators & patients.2) To provide central coordination for the study, including design & distribution of electronic case report forms & the operations manual, assistance with regulatory documents and training of site personnel. To work with Dr. Seal to resolve questions regarding study conduct, including subject eligibility, exclusionary medications, reporting of adverse events & other incidents. To monitor recruitment at each site, timeliness & accuracy of submitted data. To provide activity reports to Weill from which site payments may be generated.3) To establish a system for electronic data capture and management that will ensure timeliness & accuracy of submitted data and provision of prompt & accurate study data on an ongoing basis to Dr. Beal, the Steering Committee, Sponsor & monitoring committees & allow timely publication of the results of the study at its conclusion. This system will satisfy all relevant regulatory guidelines.4) To monitor recruitment & retention at each site.5) To liaise with the pharmacy to ensure that adequate supplies of active study medication & placebo, properly labeled, are available to each study subject on as-needed basis.6) To implement a statistical analysis plan to address the primary &secondary hypotheses of the study.7) In conjunction with the NINDS Data & Safety Monitoring Board, to devise & implement an interim monitoring scheme which will allow early termination of the study on grounds of either (i) safety, (ii)overwhelming evidence of efficacy, or (iii)futility. To prepare reports for this committee including unblinded data & to maintain & document the confidentiality of such reports.
| Parkinson Study Group QE3 Investigators; Beal, M Flint; Oakes, David et al. (2014) A randomized clinical trial of high-dosage coenzyme Q10 in early Parkinson disease: no evidence of benefit. JAMA Neurol 71:543-52 |
| Ravina, Bernard; Deuel, Lisa; Siderowf, Andrew et al. (2010) Local institutional review board (IRB) review of a multicenter trial: local costs without local context. Ann Neurol 67:258-60 |
| Logigian, E L; Martens, W B; Moxley 4th, R T et al. (2010) Mexiletine is an effective antimyotonia treatment in myotonic dystrophy type 1. Neurology 74:1441-8 |
| Montes, J; McDermott, M P; Martens, W B et al. (2010) Six-Minute Walk Test demonstrates motor fatigue in spinal muscular atrophy. Neurology 74:833-8 |
| Uc, E Y; McDermott, M P; Marder, K S et al. (2009) Incidence of and risk factors for cognitive impairment in an early Parkinson disease clinical trial cohort. Neurology 73:1469-77 |
