SLV 308 and Pramipexole for Treatment of Patients With Early Parkinson Disease

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Solvay Pharmaceuticals
• Treatments: Pramipexole

Criteria

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.