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 Klimek & 70 others Barbara 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

468 Citations (Scopus)

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

Fingerprint

Parkinson Disease
Placebos
Mesylates
Confidence Intervals
Monoamine Oxidase Inhibitors
Controlled Clinical Trials
Movement Disorders
Therapeutics
rasagiline
Controlled
Placebo
Parkinson's Disease
Maintenance
Outcome Assessment (Health Care)
Safety
Research
Confidence Interval
Efficacy
Group Treatment

ASJC Scopus subject areas

  • Arts and Humanities (miscellaneous)
  • Clinical Neurology

Cite this

Siderowf, A., Stern, M., Shoulson, I., Kieburtz, K., Oakes, D., Day, D., ... 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

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

In: Archives of Neurology, Vol. 59, No. 12, 01.12.2002, p. 1937-1943.

Research output: Contribution to journalArticle

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, Klimek, ML, Shannon, B, Ondo, W, Hunter, C, Calabrese, V, Atchison, P, Allen, C, Marshall, F, Berry, D, Gardiner, I, Miyasaki, J, Del Rizzo, L, Mendis, T, Mendis, N, Gray, P, Hubble, J, Betcher, K, Pahwa, R, Molho, E, Brown, D, Shulman, L, Rajput, A, Ewanishin, M, Stacy, M, Williamson, K, Bertoni, J, Peterson, C, Tuite, P, Ebbitt, B, Shannon, K, Jaglin, J, Tanner, C, Marek, K, Stavris, K, Aminoff, MJ, DiMinno, M, Dowling, G, Kang, UJ, Richman, J, Sethi, K, Martin, W, King, P, McInnes, G, Adler, C, LeWitt, P, DeAngelis, M, Schear, M, Gordon, MF, Winnick, R, Feldman, R, Thomas, CA, Conn, K, Brocht, A, Chadwick, C, Connolly, J, Daigneault, S, Eberly, S, Bausch, J, Josephson, L, Oliva, R, Schwid, S, Lang, A, Cox, C, Irvine, C, Nutt, J, White, W, Oren, S, Levy, R, Eyal, E, Ladkani, D & Houck, W 2002, 'A controlled trial of rasagiline in early Parkinson disease: The tempo study', Archives of Neurology, vol. 59, no. 12, pp. 1937-1943. https://doi.org/10.1001/archneur.59.12.1937
Siderowf A, Stern M, Shoulson I, Kieburtz K, Oakes D, Day D et al. A controlled trial of rasagiline in early Parkinson disease: The tempo study. Archives of Neurology. 2002 Dec 1;59(12):1937-1943. https://doi.org/10.1001/archneur.59.12.1937
Siderowf, Andrew ; Stern, Matthew ; Shoulson, Ira ; Kieburtz, Karl ; Oakes, David ; Day, Denni ; Shinaman, Aileen ; Plumb, Sandra ; Fahn, Stanley ; Blindauer, Karen ; Lew, Mark ; Hurtig, Howard ; Lloyd, Mary ; Hauser, Robert ; Gauger, Lisa ; Golbe, Lawrence ; Wojcieszek, Joanne ; Belden, Joann ; Feigin, Andrew ; Klimek, Mary Lou ; Shannon, Barbara ; Ondo, William ; Hunter, Christine ; Calabrese, Vincent ; Atchison, Paul ; Allen, Cathy ; Marshall, Frederick ; Berry, Debra ; Gardiner, Irenita ; Miyasaki, Janis ; Del Rizzo, Luisa ; Mendis, Tilak ; Mendis, Neila ; Gray, Peggy ; Hubble, Jean ; Betcher, Karen ; Pahwa, Rajesh ; Molho, Eric ; Brown, Diane ; Shulman, Lisa ; Rajput, Ali ; Ewanishin, Marianne ; Stacy, Mark ; Williamson, Kelli ; Bertoni, John ; Peterson, Carolyn ; Tuite, Paul ; Ebbitt, Brenda ; Shannon, Kathleen ; Jaglin, Jean ; Tanner, Caroline ; Marek, Kenneth ; Stavris, Karen ; Aminoff, Michael J. ; DiMinno, Mariann ; Dowling, Glenna ; Kang, Un Jung ; Richman, Judy ; Sethi, Kapil ; Martin, Wayne ; King, Pamela ; McInnes, Germaine ; Adler, Charles ; LeWitt, Peter ; DeAngelis, Maryan ; Schear, Myrna ; Gordon, Mark Forrest ; Winnick, Roberta ; Feldman, Robert ; Thomas, Cathi Ann ; Conn, Kelly ; Brocht, Alicia ; Chadwick, Chris ; Connolly, Jeannette ; Daigneault, Susan ; Eberly, Shirley ; Bausch, Janice ; Josephson, Lee ; Oliva, Rosemary ; Schwid, Steven ; Lang, Anthony ; Cox, Christopher ; Irvine, Carrie ; Nutt, John ; White, William ; Oren, Sheila ; Levy, Ruth ; Eyal, Eli ; Ladkani, David ; Houck, Wayne. / A controlled trial of rasagiline in early Parkinson disease : The tempo study. In: Archives of Neurology. 2002 ; Vol. 59, No. 12. pp. 1937-1943.
@article{be396afddefd4664bcd88c7a34698284,
title = "A controlled trial of rasagiline in early Parkinson disease: The tempo study",
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.",
author = "Andrew Siderowf and Matthew Stern and Ira Shoulson and Karl Kieburtz and David Oakes and Denni Day and Aileen Shinaman and Sandra Plumb and Stanley Fahn and Karen Blindauer and Mark Lew and Howard Hurtig and Mary Lloyd and Robert Hauser and Lisa Gauger and Lawrence Golbe and Joanne Wojcieszek and Joann Belden and Andrew Feigin and Klimek, {Mary Lou} and Barbara Shannon and William Ondo and Christine Hunter and Vincent Calabrese and Paul Atchison and Cathy Allen and Frederick Marshall and Debra Berry and Irenita Gardiner and Janis Miyasaki and {Del Rizzo}, Luisa and Tilak Mendis and Neila Mendis and Peggy Gray and Jean Hubble and Karen Betcher and Rajesh Pahwa and Eric Molho and Diane Brown and Lisa Shulman and Ali Rajput and Marianne Ewanishin and Mark Stacy and Kelli Williamson and John Bertoni and Carolyn Peterson and Paul Tuite and Brenda Ebbitt and Kathleen Shannon and Jean Jaglin and Caroline Tanner and Kenneth Marek and Karen Stavris and Aminoff, {Michael J.} and Mariann DiMinno and Glenna Dowling and Kang, {Un Jung} and Judy Richman and Kapil Sethi and Wayne Martin and Pamela King and Germaine McInnes and Charles Adler and Peter LeWitt and Maryan DeAngelis and Myrna Schear and Gordon, {Mark Forrest} and Roberta Winnick and Robert Feldman and Thomas, {Cathi Ann} and Kelly Conn and Alicia Brocht and Chris Chadwick and Jeannette Connolly and Susan Daigneault and Shirley Eberly and Janice Bausch and Lee Josephson and Rosemary Oliva and Steven Schwid and Anthony Lang and Christopher Cox and Carrie Irvine and John Nutt and William White and Sheila Oren and Ruth Levy and Eli Eyal and David Ladkani and Wayne Houck",
year = "2002",
month = "12",
day = "1",
doi = "10.1001/archneur.59.12.1937",
language = "English (US)",
volume = "59",
pages = "1937--1943",
journal = "Archives of Neurology",
issn = "0003-9942",
publisher = "American Medical Association",
number = "12",

}

TY - JOUR

T1 - A controlled trial of rasagiline in early Parkinson disease

T2 - The tempo study

AU - Siderowf, Andrew

AU - Stern, Matthew

AU - Shoulson, Ira

AU - Kieburtz, Karl

AU - Oakes, David

AU - Day, Denni

AU - Shinaman, Aileen

AU - Plumb, Sandra

AU - Fahn, Stanley

AU - Blindauer, Karen

AU - Lew, Mark

AU - Hurtig, Howard

AU - Lloyd, Mary

AU - Hauser, Robert

AU - Gauger, Lisa

AU - Golbe, Lawrence

AU - Wojcieszek, Joanne

AU - Belden, Joann

AU - Feigin, Andrew

AU - Klimek, Mary Lou

AU - Shannon, Barbara

AU - Ondo, William

AU - Hunter, Christine

AU - Calabrese, Vincent

AU - Atchison, Paul

AU - Allen, Cathy

AU - Marshall, Frederick

AU - Berry, Debra

AU - Gardiner, Irenita

AU - Miyasaki, Janis

AU - Del Rizzo, Luisa

AU - Mendis, Tilak

AU - Mendis, Neila

AU - Gray, Peggy

AU - Hubble, Jean

AU - Betcher, Karen

AU - Pahwa, Rajesh

AU - Molho, Eric

AU - Brown, Diane

AU - Shulman, Lisa

AU - Rajput, Ali

AU - Ewanishin, Marianne

AU - Stacy, Mark

AU - Williamson, Kelli

AU - Bertoni, John

AU - Peterson, Carolyn

AU - Tuite, Paul

AU - Ebbitt, Brenda

AU - Shannon, Kathleen

AU - Jaglin, Jean

AU - Tanner, Caroline

AU - Marek, Kenneth

AU - Stavris, Karen

AU - Aminoff, Michael J.

AU - DiMinno, Mariann

AU - Dowling, Glenna

AU - Kang, Un Jung

AU - Richman, Judy

AU - Sethi, Kapil

AU - Martin, Wayne

AU - King, Pamela

AU - McInnes, Germaine

AU - Adler, Charles

AU - LeWitt, Peter

AU - DeAngelis, Maryan

AU - Schear, Myrna

AU - Gordon, Mark Forrest

AU - Winnick, Roberta

AU - Feldman, Robert

AU - Thomas, Cathi Ann

AU - Conn, Kelly

AU - Brocht, Alicia

AU - Chadwick, Chris

AU - Connolly, Jeannette

AU - Daigneault, Susan

AU - Eberly, Shirley

AU - Bausch, Janice

AU - Josephson, Lee

AU - Oliva, Rosemary

AU - Schwid, Steven

AU - Lang, Anthony

AU - Cox, Christopher

AU - Irvine, Carrie

AU - Nutt, John

AU - White, William

AU - Oren, Sheila

AU - Levy, Ruth

AU - Eyal, Eli

AU - Ladkani, David

AU - Houck, Wayne

PY - 2002/12/1

Y1 - 2002/12/1

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=0036894795&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0036894795&partnerID=8YFLogxK

U2 - 10.1001/archneur.59.12.1937

DO - 10.1001/archneur.59.12.1937

M3 - Article

VL - 59

SP - 1937

EP - 1943

JO - Archives of Neurology

JF - Archives of Neurology

SN - 0003-9942

IS - 12

ER -