An Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD Patients
- Registration Number
- NCT00335374
- 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 S308.3.003 trial
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 202
Inclusion Criteria
- Patients who have completed S308.3.003 trial
Exclusion Criteria
- Patients with medically relevant abnormal findings (ECG, physical examination, AEs) at end of the maintenance phase (visit M6, week 24) of study S308.3.003
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
Trial Locations
- Locations (75)
419
🇺🇸Birmingham, Alabama, United States
413
🇺🇸Oceanside, California, United States
408
🇺🇸Oxnard, California, United States
422
🇺🇸New Haven, Connecticut, United States
403
🇺🇸Boca Raton, Florida, United States
411
🇺🇸Sarasota, Florida, United States
421
🇺🇸Augusta, Georgia, United States
410
🇺🇸Ft Wayne, Indiana, United States
417
🇺🇸Lexington, Kentucky, United States
405
🇺🇸Boston, Massachusetts, United States
Scroll for more (65 remaining)419🇺🇸Birmingham, Alabama, United States