A comparison of sumanirole versus placebo or ropinirole for the treatment of patients with early Parkinson's disease

Carlos Singer, Janice Lamb, Amanda Ellis, Gary Layton

Research output: Contribution to journalArticle

22 Citations (Scopus)

Abstract

To assess the safety and efficacy of sumanirole, a highly selective dopamine agonist, versus placebo and demonstrate its noninferiority to ropinirole, 614 patients with early Parkinson's disease (PD) were treated with sumanirole, 1 to 16 mg/day; ropinirole, 0.75 to 24 mg/day; or placebo. Primary end point in this flexible-dose, double-blind, double-dummy, parallel-group study of 40 weeks was the change in total sum of the United Parkinson's Disease Rating Scale (UPDRS) Parts II + III scores from baseline to end of maintenance. Approximately half the subjects in the sumanirole and placebo groups withdrew early from the study, most (51.8% and 68.5%, respectively) due to lack of efficacy. Of the ropinirole subjects who withdrew (50.5%), most discontinued because of adverse events. In sumanirole and ropinirole groups, mean changes from baseline of -2.48 and -5.20 in UPDRS II + III mean scores were significant versus 0.38 in the placebo group (P ≤ 0.006). Sumanirole and ropinirole are effective in the treatment of patients with early PD when compared with placebo. Noninferiority of sumanirole to ropinirole was not demonstrated, with a difference of 2.70 (90% CI, 0.92-4.49). Sumanirole was better tolerated than ropinirole.

Original languageEnglish
Pages (from-to)476-482
Number of pages7
JournalMovement Disorders
Volume22
Issue number4
DOIs
StatePublished - Mar 15 2007

Fingerprint

Parkinson Disease
Placebos
Therapeutics
Dopamine Agonists
ropinirole
U 95666E
Maintenance
Safety

Keywords

  • Dopamine agonist
  • Parkinson's disease
  • Ropinirole
  • Sumanirole

ASJC Scopus subject areas

  • Clinical Neurology
  • Neuroscience(all)

Cite this

A comparison of sumanirole versus placebo or ropinirole for the treatment of patients with early Parkinson's disease. / Singer, Carlos; Lamb, Janice; Ellis, Amanda; Layton, Gary.

In: Movement Disorders, Vol. 22, No. 4, 15.03.2007, p. 476-482.

Research output: Contribution to journalArticle

@article{31a9e109408a4a0796f249b296bc1946,
title = "A comparison of sumanirole versus placebo or ropinirole for the treatment of patients with early Parkinson's disease",
abstract = "To assess the safety and efficacy of sumanirole, a highly selective dopamine agonist, versus placebo and demonstrate its noninferiority to ropinirole, 614 patients with early Parkinson's disease (PD) were treated with sumanirole, 1 to 16 mg/day; ropinirole, 0.75 to 24 mg/day; or placebo. Primary end point in this flexible-dose, double-blind, double-dummy, parallel-group study of 40 weeks was the change in total sum of the United Parkinson's Disease Rating Scale (UPDRS) Parts II + III scores from baseline to end of maintenance. Approximately half the subjects in the sumanirole and placebo groups withdrew early from the study, most (51.8{\%} and 68.5{\%}, respectively) due to lack of efficacy. Of the ropinirole subjects who withdrew (50.5{\%}), most discontinued because of adverse events. In sumanirole and ropinirole groups, mean changes from baseline of -2.48 and -5.20 in UPDRS II + III mean scores were significant versus 0.38 in the placebo group (P ≤ 0.006). Sumanirole and ropinirole are effective in the treatment of patients with early PD when compared with placebo. Noninferiority of sumanirole to ropinirole was not demonstrated, with a difference of 2.70 (90{\%} CI, 0.92-4.49). Sumanirole was better tolerated than ropinirole.",
keywords = "Dopamine agonist, Parkinson's disease, Ropinirole, Sumanirole",
author = "Carlos Singer and Janice Lamb and Amanda Ellis and Gary Layton",
year = "2007",
month = "3",
day = "15",
doi = "10.1002/mds.21361",
language = "English",
volume = "22",
pages = "476--482",
journal = "Movement Disorders",
issn = "0885-3185",
publisher = "John Wiley and Sons Inc.",
number = "4",

}

TY - JOUR

T1 - A comparison of sumanirole versus placebo or ropinirole for the treatment of patients with early Parkinson's disease

AU - Singer, Carlos

AU - Lamb, Janice

AU - Ellis, Amanda

AU - Layton, Gary

PY - 2007/3/15

Y1 - 2007/3/15

N2 - To assess the safety and efficacy of sumanirole, a highly selective dopamine agonist, versus placebo and demonstrate its noninferiority to ropinirole, 614 patients with early Parkinson's disease (PD) were treated with sumanirole, 1 to 16 mg/day; ropinirole, 0.75 to 24 mg/day; or placebo. Primary end point in this flexible-dose, double-blind, double-dummy, parallel-group study of 40 weeks was the change in total sum of the United Parkinson's Disease Rating Scale (UPDRS) Parts II + III scores from baseline to end of maintenance. Approximately half the subjects in the sumanirole and placebo groups withdrew early from the study, most (51.8% and 68.5%, respectively) due to lack of efficacy. Of the ropinirole subjects who withdrew (50.5%), most discontinued because of adverse events. In sumanirole and ropinirole groups, mean changes from baseline of -2.48 and -5.20 in UPDRS II + III mean scores were significant versus 0.38 in the placebo group (P ≤ 0.006). Sumanirole and ropinirole are effective in the treatment of patients with early PD when compared with placebo. Noninferiority of sumanirole to ropinirole was not demonstrated, with a difference of 2.70 (90% CI, 0.92-4.49). Sumanirole was better tolerated than ropinirole.

AB - To assess the safety and efficacy of sumanirole, a highly selective dopamine agonist, versus placebo and demonstrate its noninferiority to ropinirole, 614 patients with early Parkinson's disease (PD) were treated with sumanirole, 1 to 16 mg/day; ropinirole, 0.75 to 24 mg/day; or placebo. Primary end point in this flexible-dose, double-blind, double-dummy, parallel-group study of 40 weeks was the change in total sum of the United Parkinson's Disease Rating Scale (UPDRS) Parts II + III scores from baseline to end of maintenance. Approximately half the subjects in the sumanirole and placebo groups withdrew early from the study, most (51.8% and 68.5%, respectively) due to lack of efficacy. Of the ropinirole subjects who withdrew (50.5%), most discontinued because of adverse events. In sumanirole and ropinirole groups, mean changes from baseline of -2.48 and -5.20 in UPDRS II + III mean scores were significant versus 0.38 in the placebo group (P ≤ 0.006). Sumanirole and ropinirole are effective in the treatment of patients with early PD when compared with placebo. Noninferiority of sumanirole to ropinirole was not demonstrated, with a difference of 2.70 (90% CI, 0.92-4.49). Sumanirole was better tolerated than ropinirole.

KW - Dopamine agonist

KW - Parkinson's disease

KW - Ropinirole

KW - Sumanirole

UR - http://www.scopus.com/inward/record.url?scp=34247254300&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=34247254300&partnerID=8YFLogxK

U2 - 10.1002/mds.21361

DO - 10.1002/mds.21361

M3 - Article

VL - 22

SP - 476

EP - 482

JO - Movement Disorders

JF - Movement Disorders

SN - 0885-3185

IS - 4

ER -