A controlled trial of rasagiline in early Parkinson disease: The tempo study

Andrew Siderowf, Matthew Stern, Ira Shoulson, Karl Kieburtz, David Oakes, Denni Day, Aileen Shinaman, Sandra Plumb, Stanley Fahn, Karen Blindauer, Mark Lew, Howard Hurtig, Mary Lloyd, Robert Hauser, Lisa Gauger, Lawrence Golbe, Joanne Wojcieszek, Joann Belden, Andrew Feigin, Mary Lou KlimekBarbara Shannon, William Ondo, Christine Hunter, Vincent Calabrese, Paul Atchison, Cathy Allen, Frederick Marshall, Debra Berry, Irenita Gardiner, Janis Miyasaki, Luisa Del Rizzo, Tilak Mendis, Neila Mendis, Peggy Gray, Jean Hubble, Karen Betcher, Rajesh Pahwa, Eric Molho, Diane Brown, Lisa Shulman, Ali Rajput, Marianne Ewanishin, Mark Stacy, Kelli Williamson, John Bertoni, Carolyn Peterson, Paul Tuite, Brenda Ebbitt, Kathleen Shannon, Jean Jaglin, Caroline Tanner, Kenneth Marek, Karen Stavris, Michael J. Aminoff, Mariann DiMinno, Glenna Dowling, Un Jung Kang, Judy Richman, Kapil Sethi, Wayne Martin, Pamela King, Germaine McInnes, Charles Adler, Peter LeWitt, Maryan DeAngelis, Myrna Schear, Mark Forrest Gordon, Roberta Winnick, Robert Feldman, Cathi Ann Thomas, Kelly Conn, Alicia Brocht, Chris Chadwick, Jeannette Connolly, Susan Daigneault, Shirley Eberly, Janice Bausch, Lee Josephson, Rosemary Oliva, Steven Schwid, Anthony Lang, Christopher Cox, Carrie Irvine, John Nutt, William White, Sheila Oren, Ruth Levy, Eli Eyal, David Ladkani, Wayne Houck

Research output: Contribution to journalArticle

483 Scopus citations

Abstract

Context: Monotherapy with rasagiline mesylate may be useful in early Parkinson disease (PD). Objective: To evaluate the safety and efficacy of the selective monoamine oxidase type B inhibitor rasagiline. Design: Multicenter, 26-week, parallel-group, randomized, double-blind, placebo-controlled clinical trial. Setting: Academically based movement disorders clinics. Patients: Patients with early PD not requiring dopaminergic therapy (n=404). Intervention: Research participants were randomized to rasagiline mesylate at dosages of 1 mg or 2 mg per day or matching placebo. A 1-week escalation period was followed by a 25-week maintenance period. Main Outcome Measure: The primary prespecified measure of efficacy was the change in the total Unified Parkinson's Disease Rating Scal score between baseline and 26 weeks of treatment, comparing each active treatment group with the placebo group. Results: Monotherapy with rasagiline was effective in this 26-week study. The adjusted effect size for the total Unified Parkinson's Disease Rating Scale was -4.20 units comparing 1 mg of rasagiline and placebo (95% confidence interval, -5.66 to -2.73 units; P<.001) and -3.56 units comparing a 2-mg dosage and placebo (95% confidence interval, -5.04 to -2.08 units; P <.001). There were no meaningful differences in the frequency of adverse events or premature withdrawals among the treatment groups. Conclusions: Rasagiline is effective as monotherapy for patients with early PD. The 2 dosages in this trial were both effective relative to placebo. Further study is warranted to evaluate the longer-term effects of rasagiline in PD.

Original languageEnglish (US)
Pages (from-to)1937-1943
Number of pages7
JournalArchives of neurology
Volume59
Issue number12
DOIs
StatePublished - Dec 1 2002

ASJC Scopus subject areas

  • Arts and Humanities (miscellaneous)
  • Clinical Neurology

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    Siderowf, A., Stern, M., Shoulson, I., Kieburtz, K., Oakes, D., Day, D., Shinaman, A., Plumb, S., Fahn, S., Blindauer, K., Lew, M., Hurtig, H., Lloyd, M., Hauser, R., Gauger, L., Golbe, L., Wojcieszek, J., Belden, J., Feigin, A., ... Houck, W. (2002). A controlled trial of rasagiline in early Parkinson disease: The tempo study. Archives of neurology, 59(12), 1937-1943. https://doi.org/10.1001/archneur.59.12.1937