Safety and Efficacy Study of SYN115 in Parkinson's Patients Using Levodopa to Treat End of Dose Wearing Off

Summary

The purpose of this research study is to test the effect of SYN115 compared to placebo (a "sugar pill" that looks like SYN115 but does not include active drug) on movement during the "on" and "off" states as well as other symptoms that some patients with Parkinson's disease experience. This study will also look at whether or not patients with Parkinson's disease experience "side-effects" with SYN115.

Timeline

Start

2011-03

Primary completion

2012-10

Completion

2012-10

Outcome

Met primary endpoint

paper Compared with placebo, mean daily off-time was significantly reduced in the combined tozadenant 120 mg twice-daily and 180 mg twice-daily group PMID 25008546 ↗

paper the tozadenant 120 mg twice-daily group (-1·1 h, -1·8 to -0·4; p=0.0039) PMID 25008546 ↗

Publications

• Hauser RA, Olanow CW, Kieburtz KD, Pourcher E, Docu-Axelerad A, Lew M, Kozyolkin O, Neale A, Resburg C, Meya U, Kenney C, Bandak S. Tozadenant (SYN115) in patients with Parkinson's disease who have motor fluctuations on levodopa: a phase 2b, double-blind, randomised trial. Lancet Neurol. 2014 Aug;13(8):767-76. doi: 10.1016/S1474-4422(14)70148-6. Epub 2014 Jul 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tozadenant	Small molecule	60 mg	Oral
Subject	Tozadenant	Small molecule	120 mg	Oral
Subject	Tozadenant	Small molecule	180 mg	Oral
Subject	Tozadenant	Small molecule	240 mg	Oral
Background	Levodopa	Unknown	—	Intravenous

Indications