Status:
COMPLETED
SLV308 for Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations
Lead Sponsor:
Solvay Pharmaceuticals
Conditions:
Advanced Stage Parkinson's Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE3
Brief Summary
This study is a multicenter, randomized, double blind, parallel group study of 3 months' treatment with SLV308 administered as a monotherapy in patients with advance stage PD. An open label safety ext...
Eligibility Criteria
Inclusion
- Diagnosis of idiopathic Parkinson's Disease,
- advance stage of disease,
- Modified Hoehn \& Yahr stage II-IV,
- presence of a recognizable 'on' and 'off' state (motor fluctuations) and stable treatment with levodopa for at least 28 days prior to randomization
Exclusion
- 'on-off' phenomena or 'yo-yoing' and/or an abrupt unpredictable loss of efficacy unrelated to the timing of L-DOPA administration,
- Prevalent expression of troublesome dyskinesias during 'on' time at waking hours,
- Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists,
- Previous surgery for the treatment of PD
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
295 Patients enrolled
Trial Details
Trial ID
NCT00406588
Start Date
March 1 2007
End Date
May 1 2008
Last Update
February 27 2015
Active Locations (87)
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1
Site 223
Birmingham, Alabama, United States
2
Site 220
La Jolla, California, United States
3
Site 211
San Francisco, California, United States
4
Site 214
Fort Lauderdale, Florida, United States