Long-term safety and efficacy of preladenant in subjects with fluctuating Parkinson's disease.

Abstract

BACKGROUND:

Preladenant is a selective adenosine A₂A receptor antagonist under investigation for Parkinson's disease treatment.

METHODS:

A phase 2 36-week open-label follow-up of a double-blind study using preladenant 5 mg twice a day as a levodopa adjunct in 140 subjects with fluctuating Parkinson's disease was conducted. The primary end point was adverse event (AE) assessment. Secondary (efficacy) analyses included hours/day spent in OFF and ON states and dyskinesia prevalence/severity.

RESULTS:

The 36-week open-label phase was completed by 106 of 140 subjects (76%). AE-related treatment discontinuations occurred in 19 subjects (14%). Treatment-emergent AEs, reported by ≥15% of subjects, were dyskinesia (33%) and constipation (19%). Preladenant 5 mg twice a day provided OFF time reductions (1.4-1.9 hours/day) and ON time increases (1.2-1.5 hours/day) throughout the 36-week treatment relative to the baseline of the double-blind study.

CONCLUSIONS:

Long-term preladenant treatment (5 mg twice a day) was generally well tolerated and provided sustained OFF time reductions and ON time increases.

• Authors: Stewart A Factor, Kenneth Wolski, Daniel M Togasaki, Susan Huyck, Marc Cantillon, T W Ho, Robert A Hauser, Emmanuelle Pourcher
• Journal: Movement disorders : official journal of the Movement Disorder Society (Mov Disord) Vol. 28 Issue 6 Pg. 817-20 (Jun 2013) ISSN: 1531-8257 [Electronic] United States
• PMID: 23589371 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2013 Movement Disorder Society.

Chemical References

• Antiparkinson Agents
• Pyrimidines
• Triazoles
• 2-(2-furanyl)-7-(2-(4-(4-(2-methoxyethoxy)phenyl)-1-piperazinyl)ethyl)-7H-pyrazolo(4,3-e)(1,2,4)triazolo(1,5-c)pyrimidine-5-amine

Topics

• Aged
• Antiparkinson Agents (therapeutic use)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Humans
• Longitudinal Studies
• Middle Aged
• Parkinson Disease (drug therapy, physiopathology)
• Pyrimidines (therapeutic use)
• Severity of Illness Index
• Triazoles (therapeutic use)