Accepted for Publication: October 25, 2013.
Study concept and design: Schwarzschild, Ascherio, Kieburtz, Macklin.
Acquisition of data: Espay, Gartner, Hung, Bwala, Lenehan, Encarnacion, Ainslie, Castillo, Togasaki, Barles, Friedman, Niles, Carter, Murray, Goetz, Jaglin, Ahmed, D. S. Russell, Cotto, Goudreau, D. Russell, Parashos, Ede, Saint-Hilaire, Thomas, James, Stacy, Johnson, Gauger, de Marcaida, Thurlow, Isaacson, Carvajal, Rao, Cook, Hope-Porche, McClurg, Grasso, Logan, Orme, Ross, Brocht, Constantinescu, Sharma, Venuto, Weber, Eaton.
Analysis and interpretation of data: Schwarzschild, Beal, Cudkowicz, Curhan, Hare, Hooper, Kieburtz, Macklin, Oakes, Rudolph, Shoulson, Tennis.
Drafting of the manuscript: Schwarzschild, Ascherio, Macklin.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Macklin.
Obtaining funding: Schwarzschild, Ascherio, Kieburtz, Macklin.
Administrative, technical, and material support: Espay, Hung, Bwala, Lenehan, Encarnacion, Ainslie, Castillo, Togasaki, Barles, Niles, Murray, Goetz, Jaglin, D. S. Russell, Goudreau, D. Russell, Parashos, Ede, James, Johnson, de Marcaida, Thurlow, Isaacson, Rao, Cook, Hope-Porche, McClurg, Grasso, Logan, Orme, Ross, Brocht, Constantinescu, Sharma, Venuto, Weber, Eaton.
Study supervision: Schwarzschild, Ascherio, Beal, Cudkowicz, Curhan, Hare, Hooper, Kieburtz, Macklin, Oakes, Rudolph, Shoulson, Tennis.
Published Online: December 23, 2013. doi:10.1001/jamaneurol.2013.5528.
Conflict of Interest Disclosures: None of direct relevance to the drug development of inosine, the potential therapy under study. Note that in accordance with conflict of interest policy of Parkinson Study Group (http://www.parkinson-study-group.org/parkinson-research/constitution-and-bylaws) all SURE-PD steering committee members, site investigators, and site coordinators should have no financial relationship with any involved company during the study. Although the study received no commercial support, Kyowa Hakko USA Inc, its affiliate Kyowa Pharmaceutical Inc, and their parent company Kyowa Hakko Kirin Co Ltd were designated as the only “involved companies.” The designations were based on the use of Kyowa Hakko USA as the vendor from which inosine was obtained (as the active pharmaceutical ingredient for study drug manufacture) through an unsubsidized retail purchase. All authors provided signed attestation annually that they have no financial relationship with any involved company during the study, except that Dr Stacy indicated in 2013 that in 2012 he renewed a consulting relationship with Kyowa Hakko Kirin Co Ltd over a drug (istradefylline) intended to treat PD that is otherwise unrelated to inosine. Dr Goetz reports consulting and advisory board membership with honoraria from AOP Orphan, Addex Pharma, Advanced Studies of Medicine, Boston Scientific, CHDI, Health Advances, ICON Clinical Research, Ingenix (i3 Research), National Institutes of Health, Neurocrine, Oxford Biomedica, and Synthonics. He received grants/research funding from the National Institutes of Health and the Michael J. Fox Foundation for Parkinson’s Research (MJFF). Dr Goetz directs the Rush Parkinson’s Disease Research Center that receives support from the Parkinson’s Disease Foundation. He directs the translation program for the Movement Disorder Society–sponsored revision of the UPDRS and the Unified Dyskinesia Rating Scale and receives funds from the Movement Disorder Society for this effort. He also received honoraria from the Movement Disorder Society, American Academy of Neurology, University of Pennsylvania, University of Chicago, and University of Luxembourg. He has received royalties from Oxford University Press, Elsevier Publishers, and Wolters Kluwer Health Lippincott, Wilkins and Williams. No other disclosures were reported.
Funding/Support: This project was funded by a grant from the MJFF. Additional support was provided by National Institutes of Health grant K24NS060991, Harvard NeuroDiscovery Center, the RJG Foundation, and the Parkinson’s Disease Foundation Advancing Parkinson’s Therapies initiative.
Disclaimer: The views, findings, and opinions expressed in this publication are those of the authors and do not necessarily represent those of the MJFF. Dr Shoulson is the JAMA Neurology Section Editor for Clinical Trials but was not involved in the review process or the acceptance of the manuscript.
Role of the Sponsor: No funder was involved in the design and conduct of the study, other than through the provisions of funds for the study. No funder had a role in the collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Additional Contributions: We are grateful for the invaluable contributions of the study participants and their families, as well as for the key contributions and dedication of the Data and Safety Monitoring Committee members: Caroline M. Tanner, MD, PhD (chair), Bruce Levin, PhD, Grace S. Liang, MD, and Nina E. Tolkoff-Rubin, MD; MJFF staff and leadership serving as grantor/nonvoting members of the Steering Committee: Brian K. Fiske, PhD, Alison Urkowitz, and Todd B. Sherer, PhD; Project Advisors to the MJFF: Jeffrey M. Bronstein, MD, PhD, and David M. Weiner, MD; Clinical Materials Services Unit (www.clinicalmaterial.com) of the Center for Human Experimental Therapeutics at the University of Rochester Medical Center: Patrick Bolger, Tim Hackett, Cornelia Kamp, MBA, Ellen Weinberger, and Joan Woodcook; and other contributing clinical site staff including Linda Baldwin (deceased).