Status:
COMPLETED
Ascending Dose Tolerability/Safety of SLV308 for the Treatment of Parkinson's Disease
Lead Sponsor:
Solvay Pharmaceuticals
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- Unclear diagnosis or a suspicion of other parkinsonian syndromes
- Have undergone surgical treatment for PD
- History of non-response to L-dopa.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00134251
Start Date
October 1 2005
Last Update
January 30 2009
Active Locations (10)
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1
Site 16
Plovdiv, Bulgaria
2
Site 11
Sofia, Bulgaria
3
Site 12
Sofia, Bulgaria
4
Site 13
Sofia, Bulgaria