A Dose Finding Study of Preladenant (SCH 420814) for the Treatment of Parkinson's Disease (PD) in Japanese Patients (P06402)

Summary

This study is to evaluate the efficacy of a range of preladenant doses compared with placebo in participants with moderate to severe Parkinson's disease (PD) experiencing motor fluctuations and receiving a stable dose of levodopa (L-dopa), as measured by "off" time. Participants will continue to receive their stable regimen of L-dopa plus any adjunct medications during the study as prescribed by their physician. Several classes of adjunct medications may be used, including Amantadine, anticholinergics, dopa decarboxylase inhibitors, and dopamine agonists. Primary Hypothesis: At least the 10 mg twice daily dose of preladenant is superior to placebo as measured by the change from Baseline to Week 12 in the mean "off" time.

Timeline

Start

2011-02-25

Primary completion

2013-06-01

Completion

2013-06-01

Outcome

Missed primary endpoint

registry Preladenant 2 mg vs Placebo; p = 0.0564; Difference in Least Squares Mean -0.7 NCT01294800 ↗

registry Preladenant 5 mg vs Placebo; p = 0.1844; Difference in Least Squares Mean -0.5 NCT01294800 ↗

registry Preladenant 10 mg vs Placebo; p = 0.3386; Difference in Least Squares Mean -0.3 NCT01294800 ↗

paper preladenant in this study did not demonstrate statistically significant efficacy PMID 27632893 ↗

Publications

• Results Hattori N, Kikuchi M, Adachi N, Hewitt D, Huyck S, Saito T. Adjunctive preladenant: A placebo-controlled, dose-finding study in Japanese patients with Parkinson's disease. Parkinsonism Relat Disord. 2016 Nov;32:73-79. doi: 10.1016/j.parkreldis.2016.08.020. Epub 2016 Aug 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Preladenant	Small molecule	2 mg	Oral
Subject	Preladenant	Small molecule	5 mg	Oral
Subject	Preladenant	Small molecule	10 mg	Oral

Indications