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December 2007

Notice of Redundant Publication: “Transdermal Rotigotine: Double-blind, Placebo-Controlled Trial in Parkinson Disease” (Arch Neurol. 2007;64[5]:676-682)—Reply

Arch Neurol. 2007;64(12):1801. doi:10.1001/archneur.64.12.1801

In reply

We respectfully but strongly disagree with Dr Rosenberg's perception that the 2 cited articles are redundant. We welcome the opportunity to respond to his letter and, in the limited space allowed, explain why the 2 papers are clearly different. While the original article reported the primary efficacy and safety results of the SP 512 Transdermal Rotigotine Phase 3 Pivotal Clinical Trial in Early Parkinson's Disease,1 the second article focused on the secondary outcome variables and plasma pharmacokinetics of rotigotine administered once daily via a novel transdermal delivery system.2 In our recent communications to Dr Rosenberg, we explained that the results of this important study and the many outcome variables along with unique pharmacokinetic data were too extensive to report in a single article submitted to Neurology. Therefore, in the Archives paper,2 we reported primarily data not described in the Neurology paper,1 such as the effects of rotigotine versus placebo on Clinical Global Impression (CGI) scores, percentage of patients considered moderately to markedly ill, Epworth Sleepiness Scale (ESS) scores, quality of life measures (EQ-5D Index and EQ-5D Health Score), plasma concentrations of rotigotine, and prolactin levels in addition to presenting different aspects of the design of the study and the Unified Parkinson's Disease Rating Scale (UPDRS) subscores. The only overlap between the 2 articles is the report of 20% response rate and the adverse events, which were included in response to queries by 1 of the reviewers for Archives. In submitting the 2 separate papers, we intended to report as completely as possible the data generated by the large multicenter study and in the interest of full disclosure. We were, therefore, surprised by the allegations raised in Dr Rosenberg's letter because we never considered the 2 papers duplicative or redundant. Reporting different aspects of clinical trials, such as primary and secondary outcome variables, in separate publications is a common and accepted practice, given the wide range of numerous assessment measures generated by large studies and limitations of space imposed by various scientific journals. We are reassured that an independent review by other academic neurologists came to the same conclusion that the 2 papers were clearly different in intent and content.

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