SLV 308 and Pramipexole for Treatment of Patients With Early Parkinson Disease
Phase 3
Completed
- Conditions
- Early Stage Parkinson Disease
- Interventions
- Registration Number
- NCT00335166
- Lead Sponsor
- Solvay Pharmaceuticals
- Brief Summary
This is a multicenter, randomized, double blind, parallel group study of 6 months' treatment with SLV308 as 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
- 330
Inclusion Criteria
- Diagnosis of idiopathic Parkinson's Disease, Modified Hoehn & Yahr up to stage III, UPDRS motor score (part III) must have a total of at least 10 at baseline.
Exclusion Criteria
- Diagnosis is unclear or a suspicion of other parkinsonian syndromes,
- Patients who have undergone surgery for the treatment of PD,
- Current presence of dyskinesias,
- Motor fluctuations or loss of postural reflexes,
- A history of non-response to an adequate course of l-dopa or a dopamine agonist,
- Patients for whom previously treatment with dopamine agonists needed to terminate because of induction of psychosis (i.e. hallucinations) and /or sleep attacks.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Pardaprunox - 2 pramipexole - 3 Placebo Comparator -
- Primary Outcome Measures
Name Time Method UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment 24 weeks
- 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. 24 weeks
Trial Locations
- Locations (89)
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 (79 remaining)419🇺🇸Birmingham, Alabama, United States