A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (PD) (P05664)

Summary

This is a one year, 2-part study to determine the efficacy and safety of preladenant, an adenosine type 2a (A2a) receptor antagonist. The purpose of Part 1 (first 26 weeks) is to determine if preladenant is effective in the treatment of early Parkinson's Disease. The purpose of Part 2 (second 26 weeks) is to determine if preladenant is safe and well tolerated. The primary efficacy hypothesis is that at least the 10 mg twice daily dose of preladenant is superior to placebo as measured by the change from Baseline to Week 26 in the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Parts 2 and 3 scores (UPDRS2+3).

Timeline

Start

2010-07-06

Primary completion

2013-07-16

Completion

2013-07-16

Outcome

Missed primary endpoint

Stopped (Business): “Termininated for business reasons”

paper Neither preladenant nor rasagiline was superior to placebo after 26 weeks. PMID 28490648 ↗

Publications

• Results Stocchi F, Rascol O, Hauser RA, Huyck S, Tzontcheva A, Capece R, Ho TW, Sklar P, Lines C, Michelson D, Hewitt DJ; Preladenant Early Parkinson Disease Study Group. Randomized trial of preladenant, given as monotherapy, in patients with early Parkinson disease. Neurology. 2017 Jun 6;88(23):2198-2206. doi: 10.1212/WNL.0000000000004003. Epub 2017 May 10.

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
Comparator	Rasagiline	Small molecule	1 mg	Oral

Indications