HOMEPRODUCTSCOMPANYCONTACTFAQResearchDictionaryPharmaSign Up FREE or Login

Istradefylline for Parkinson's disease patients experiencing motor fluctuations: results of the KW-6002-US-018 study.

AbstractBACKGROUND:
Istradefylline (KW-6002) is a selective adenosine A(2A) receptor antagonist investigated as adjunctive therapy to levodopa in PD patients with motor response complications. In Phase 2b/3 studies, Istradefylline reduced OFF time without worsening troublesome dyskinesia and was well tolerated.
METHODS:
A randomized, 12-week, double-blind, placebo-controlled parallel-group study evaluated the efficacy of 10, 20, and 40 mg/day of Istradefylline in patients on levodopa therapy with motor response complications. The primary outcome measure was change from baseline to endpoint in the percentage of awake time/day spent in the OFF state as determined by patient diary.
RESULTS:
Six hundred and ten patients were randomized. Five hundred and eighty four patients were included in the Intent-to-treat (ITT) group-146 placebo patients and 149 in the 10 mg, 144 in the 20, and 145 patients in the 40 mg Istradefylline groups. Baseline demographics were similar between groups. Treatment cohorts had been diagnosed an average of 9 years diagnosis and 3.6 years from the onset of motor fluctuations; at baseline they had an average of 6.7 h of OFF time and an average UPDRS motor score of 22 when ON. At endpoint, the amount and percentage of OFF time did not differ between Istradefylline and placebo, however a dose-ordering response was observed. Changes from baseline in the UPDRS motor score in the on state for the 40 mg were modest but significant compared to placebo (2.9 vs. 0.8; p < 0.05).
CONCLUSIONS:
Although Istradefylline did not impact OFF time duration, it significantly improved motor score at 40 mg/day.
AuthorsEmmanuelle Pourcher, Hubert H Fernandez, Mark Stacy, Akihisa Mori, Rocco Ballerini, Philip Chaikin
JournalParkinsonism & related disorders (Parkinsonism Relat Disord) Vol. 18 Issue 2 Pg. 178-84 (Feb 2012) ISSN: 1873-5126 [Electronic] England
PMID22000279 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
CopyrightCopyright © 2011 Elsevier Ltd. All rights reserved.
Chemical References
  • Adenosine A2 Receptor Antagonists
  • Antiparkinson Agents
  • Purines
  • istradefylline
Topics
  • Adenosine A2 Receptor Antagonists (therapeutic use)
  • Aged
  • Antiparkinson Agents (therapeutic use)
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Motor Skills (drug effects)
  • Parkinson Disease (drug therapy, physiopathology)
  • Purines (therapeutic use)

Join CureHunter, for free Research Interface BASIC access!

Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease. Find out why thousands of doctors, pharma researchers and patient activists around the world use CureHunter every day.
Realize the full power of the drug-disease research graph!


Choose Username:
Email:
Password:
Verify Password:
Enter Code Shown: