SLV308 for Treatment of Patients With Early Parkinson's Disease
- Conditions
- Early Stage Parkinson's Disease
- Interventions
- Drug: Placebo
- Registration Number
- NCT00269516
- Lead Sponsor
- Solvay Pharmaceuticals
- Brief Summary
This study is a multicenter, randomized, double blind, parallel group study of 6 months' treatment with SLV308 administered as a monotherapy in patients with early 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 468
- Diagnosis of idiopathic Parkinson's Disease,
- Early stage of disease, Modified Hoehn & Yahr up to stage III,
- UPDRS motor score (part III) 10 at baseline.
- Diagnosis is unclear or a suspicion of other parkinsonian syndromes,
- Patients who have undergone surgery for the treatment of PD,
- Presence of dyskinesias,
- Motor fluctuations or loss of postural reflexes,
- Clinically significant abnormalities,
- Patients treated with L-dopa or dopamine agonists currently or in the past (for more than 3 months in total),
- Antipsychotic.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Pardoprunox - 2 Pardoprunox - 3 Pardoprunox - 4 Placebo -
- Primary Outcome Measures
Name Time Method UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment 6 months
- Secondary Outcome Measures
Name Time Method UPDRS part 2 (ADL score); CGI-Improvement; PDQ-39 total score: all change from baseline to 24 weeks maintenance treatment 6 months
Trial Locations
- Locations (128)
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 (118 remaining)Site 284🇺🇸Huntsville, Alabama, United States