An Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD Patients
- Registration Number
- NCT00332917
- Lead Sponsor
- Solvay Pharmaceuticals
- Brief Summary
This is a multicenter, 6 months open label safety extension study for all patients who are willing and eligible to continue from the pivotal, double-blind S308.3.001 trial
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 224
- Patients who have completed S308.3.001 trial
- Patients with medically relevant abnormal findings (ECG, physical examination, AEs) at end of the maintenance phase (visit M6, week 24) of study S308.3.001
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Pardoprunox -
- Primary Outcome Measures
Name Time Method Safety: laboratory data, adverse events, vital signs, ECG 24 weeks
- Secondary Outcome Measures
Name Time Method UPDRS parts 1, 2 and 3, CGI-severity, CGI-improvement, PDQ-39 total score: all change from baseline 24 weeks
Related Research Topics
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Trial Locations
- Locations (130)
Site 284
🇺🇸Huntsville, Alabama, United States
Site 274
🇺🇸Little Rock, Arkansas, United States
Site 283
🇺🇸Fountain Valley, California, United States
Site 277
🇺🇸La Jolla, California, United States
Site 271
🇺🇸San Francisco, California, United States
Site 279
🇺🇸Ft Lauderdale, Florida, United States
Site 293
🇺🇸Gainsville, Florida, United States
Site 282
🇺🇸Port Charlotte, Florida, United States
Site 285
🇺🇸Sunrise, Florida, United States
Site 273
🇺🇸Tampa, Florida, United States
Scroll for more (120 remaining)Site 284🇺🇸Huntsville, Alabama, United States