Istradefylline as monotherapy for Parkinson disease

Results of the 6002-US-051 trial

H. H. Fernandez, D. R. Greeley, R. M. Zweig, Joanne Wojcieszek, A. Mori, N. M. Sussman

Research output: Contribution to journalArticle

74 Citations (Scopus)

Abstract

Objective: 6002-US-051 was a 12-week, double-blind study evaluating the safety and efficacy of istradefylline, a selective A2A adenosine receptor antagonist, as monotherapy in patients with Parkinson's disease (PD). Methods: Patients with Hoehn-Yahr stages 1-2.5 who had not received dopaminergic drugs in the past 30 days or levodopa for >30 days at anytime were randomized to 40 mg/day istradefylline or placebo. The primary efficacy outcome was the change from Baseline to Endpoint in the Unified Parkinson's Disease Rating Scale (UPDRS) Subscale III score. Safety was assessed by physical examination, laboratory tests, electrocardiograms, and adverse event monitoring. Results: 176 patients comprised the intent-to-treat population. Although istradefylline showed numerically greater improvements in UPDRS Subscale III at each time point and reached statistical significance at Week 2 (LS mean difference = -1.47), it did not show statistically significant improvement from placebo for the primary endpoint (least square [LS] mean difference = -1.11). Similar proportions of patients in each group experienced treatment-emergent adverse events (63% istradefylline, 65% placebo). Conclusions: Istradefylline, as monotherapy in patients with PD, is safe and well tolerated. However, efficacy in improving motor symptoms in early PD was not statistically demonstrated by this study.

Original languageEnglish
Pages (from-to)16-20
Number of pages5
JournalParkinsonism and Related Disorders
Volume16
Issue number1
DOIs
StatePublished - Jan 2010

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Parkinson Disease
Placebos
Least-Squares Analysis
Adenosine A2 Receptor Antagonists
Safety
Dopamine Agents
Levodopa
Double-Blind Method
Physical Examination
Electrocardiography
istradefylline
Population
Therapeutics

Keywords

  • Adenosine A receptor antagonist
  • Istradefylline
  • KW-6002
  • Monotherapy
  • Parkinson

ASJC Scopus subject areas

  • Geriatrics and Gerontology
  • Clinical Neurology
  • Neurology

Cite this

Istradefylline as monotherapy for Parkinson disease : Results of the 6002-US-051 trial. / Fernandez, H. H.; Greeley, D. R.; Zweig, R. M.; Wojcieszek, Joanne; Mori, A.; Sussman, N. M.

In: Parkinsonism and Related Disorders, Vol. 16, No. 1, 01.2010, p. 16-20.

Research output: Contribution to journalArticle

Fernandez, H. H. ; Greeley, D. R. ; Zweig, R. M. ; Wojcieszek, Joanne ; Mori, A. ; Sussman, N. M. / Istradefylline as monotherapy for Parkinson disease : Results of the 6002-US-051 trial. In: Parkinsonism and Related Disorders. 2010 ; Vol. 16, No. 1. pp. 16-20.
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