MedPath

An Open Label SLV308 Safety Extension to Study S308.3.002 in Patients With Parkinson's Disease Experiencing Motor Fluctuations.

Phase 3
Completed
Conditions
Advanced Stage Parkinson's Disease
Interventions
Registration Number
NCT00407095
Lead Sponsor
Solvay Pharmaceuticals
Brief Summary

This study is a multicenter, 9 months, open label extension study for all patients who are willing and eligible to continue from the pivotal, double-blind S308.3.002 study.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
140
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
1Pardoprunox-
Primary Outcome Measures
NameTimeMethod
Safety: laboratory data, adverse events, vital signs, ECG36 weeks
Secondary Outcome Measures
NameTimeMethod
On' and 'off' time recording, UPDRS parts 1-4, CGI-improvement, PDQ-39 total score: all change from baseline36 weeks

Trial Locations

Locations (87)

S308.3.007 Site # 220

🇺🇸

LaJolla, California, United States

S308.3.007 Site # 211

🇺🇸

San Francisco, California, United States

S308.3.007 Site # 214

🇺🇸

Fort Lauderdale, Florida, United States

S308.3.007 Site # 218

🇺🇸

Gainsville, Florida, United States

S308.3.007 Site # 213

🇺🇸

Tampa, Florida, United States

S308.3.007 Site # 219

🇺🇸

Augusta, Georgia, United States

S308.3.007 Site # 221

🇺🇸

Chicago, Illinois, United States

S308.3.007 Site # 216

🇺🇸

Kansas City, Kansas, United States

S308.3.007 Site # 224

🇺🇸

Lexington, Kentucky, United States

S308.3.007 Site # 212

🇺🇸

East Lansing, Michigan, United States

Scroll for more (77 remaining)
S308.3.007 Site # 220
🇺🇸LaJolla, California, United States

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.