Authors: Lew, Mark F.¹; Pahwa, Rajesh²; Leehey, Maureen³; Bertoni, John⁴; Kricorian, Greg⁵; The Zydis Selegiline Study Group,

Source: Current Medical Research and Opinion, Volume 23, Number 4, April 2007 , pp. 741-750(10)

Publisher: Informa Healthcare

Abstract:

Objective: Patients receiving levodopa for Parkinson's disease experience motor fluctuations and immobility ('off' episodes) between doses. This study assessed adjunctive Zelapar (selegiline orally disintegrating tablet (ODT)) for managing off episodes and for long-term safety.

Methods: This open-label extension evaluated long-term safety, efficacy, and tolerability of adjunctive selegiline ODT 2.5 mg in patients who completed either of two large phase 3 double-blind studies. The study was to end after 12 months but was amended to be open-ended. Investigators could increase levodopa doses and introduce controlled-release formulations of levodopa or dopamine agonists if warranted. Additionally, results of a small randomized trial of open-label selegiline ODT 1.25 mg in comparison to conventional selegiline was added only to the safety analysis. Efficacy variables included changes in daily off time and Patient's Global Impression of Improvement (PGI-I) and Clinical Global Impressions Severity of Disease (CGI-S) ratings. Safety assessments included adverse events and oropharyngeal findings.

Results: This study enrolled 254 patients: 248 from the large phase 3 studies (efficacy analysis) and an additional six from the prior open-label comparison (safety analysis) in order to evaluate a larger population for safety purposes. Mean reduction from baseline in daily off time was 9.4% (1.6 h) for patients previously given selegiline ODT, 6.0% (1.2 h) for those switched from placebo, and 8.1% (1.4 h) overall. PGI-I and CGI-S ratings indicated little or no change from baseline. Treatment-related adverse events occurred in 132 (52%) patients. No severe oral irritations were attributed to selegiline ODT or prompted discontinuation.

Conclusions: Long-term selegiline ODT 2.5 mg/day was effective, safe, and well tolerated in patients with Parkinson's disease experiencing off episodes during levodopa therapy.

Keywords: CLINICAL STUDY; LEVODOPA; MOTOR FLUCTUATIONS; PARKINSON'S DISEASE; SELEGILINE ORALLY DISINTEGRATING TABLET

Document Type: Research article

DOI: http://dx.doi.org/10.1185/030079906X167697

Affiliations: 1: Keck/University of Southern California School of Medicine, Los Angeles, CA, USA 2: Department of Neurology and the Parkinson's Disease and Movement 3: Department of Neurology and Movement Disorders Program, University of Colorado at Denver Health Sciences Center, Denver, CO, USA 4: Department of Neurology, Creighton University Medical Center, Omaha, NE, USA 5: Valeant Pharmaceuticals International, Aliso Viejo, CA, USA

Publication date: 2007-04-01

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