Ascending Dose Tolerability/Safety of SLV308 for the Treatment of Parkinson's Disease
Phase 3
Completed
- Conditions
- Parkinson's Disease
- Registration Number
- NCT00134251
- Lead Sponsor
- Solvay Pharmaceuticals
- Brief Summary
This study is a multicenter, randomized, double-blind, placebo controlled, parallel group study of a seven-week ascending dose period of SLV308 adjunctive to L-dopa treatment in patients with advanced stage Parkinson's disease (PD) and dose-dependent motor fluctuations. Patients (outpatients) will be randomized to one of three different treatment arms.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Patients who have signed an informed consent; diagnosis of idiopathic PD.
- Presence of recognizable "on" and "off" stages
- Minimum hours of "off" time per day of 2.5 hours
- Able to keep diaries.
Exclusion Criteria
- Unclear diagnosis or a suspicion of other parkinsonian syndromes
- Have undergone surgical treatment for PD
- History of non-response to L-dopa.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Site 34
🇷🇸Belgrade, Serbia
Site 14
🇧🇬Sofia, Bulgaria
Site 33
🇷🇸Nis, Serbia
Site 15
🇧🇬Sofia, Bulgaria
Site 21
🇲🇹Guardamangia, Malta
Site 12
🇧🇬Sofia, Bulgaria
Site 13
🇧🇬Sofia, Bulgaria
Site 31
🇷🇸Belgrade, Serbia
Site 16
🇧🇬Plovdiv, Bulgaria
Site 11
🇧🇬Sofia, Bulgaria