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

Solvay

Status and phase: Completed; Phase 3

Conditions: Early Stage Parkinson Disease

Treatments: Drug: Placebo Comparator; Drug: pramipexole; Drug: Pardaprunox

Study type: Interventional

Funder types: Industry

Identifiers

NCT00335166

S308.3.003

Not requested yet

Details and patient eligibility

About

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.

Enrollment: 330 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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330 participants in 3 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Pardaprunox

2

Active Comparator group

Treatment:

Drug: pramipexole

3

Placebo Comparator group

Treatment:

Drug: Placebo Comparator