drugset / Trial / NCT00406588

SLV308 for Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations

NCT00406588 ↗

Phase 3 Completed 295 enrolled Solvay Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is a multicenter, randomized, double blind, parallel group study of 3 months' treatment with SLV308 administered as a monotherapy in patients with advance stage PD. An open label safety extension to this study is planned as a separate protocol for patients who are willing and eligible to participate.

Timeline

Start
2007-03
Primary completion
2008-04
Completion
2008-05

Outcome

Met primary endpoint

paper Pardoprunox significantly reduced OFF time versus placebo (-1.62 h/day versus -0.92 h/day, respectively, p = 0.0215). PMID 22316635 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Pardoprunox Small molecule 12 mg —
Subject Pardoprunox Small molecule 42 mg —
Background Levodopa Unknown — —

Indications