Status:
COMPLETED
SLV 308 and Pramipexole for Treatment of Patients With Early Parkinson Disease
Lead Sponsor:
Solvay Pharmaceuticals
Conditions:
Early Stage Parkinson Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2008
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT00335166
Start Date
November 1 2006
End Date
February 1 2008
Last Update
April 3 2008
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