SLV308 for Treatment of Patients With Early Parkinson's Disease

Solvay

Status and phase: Completed; Phase 3

Conditions: Early Stage Parkinson's Disease

Treatments: Drug: Placebo; Drug: Pardoprunox; Drug: pardoprunox

Study type: Interventional

Funder types: Industry

Identifiers

NCT00269516

S308.3.001

Details and patient eligibility

About

This study is a multicenter, randomized, double blind, parallel group study of 6 months' treatment with SLV308 administered as a 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: 468 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of idiopathic Parkinson's Disease,
• Early stage of disease, Modified Hoehn & Yahr up to stage III,
• UPDRS motor score (part III) 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,
• Presence of dyskinesias,
• Motor fluctuations or loss of postural reflexes,
• Clinically significant abnormalities,
• Patients treated with L-dopa or dopamine agonists currently or in the past (for more than 3 months in total),
• Antipsychotic.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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468 participants in 4 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: pardoprunox

2

Experimental group

Treatment:

Drug: Pardoprunox

Drug: Pardoprunox

3

Experimental group

Treatment:

Drug: Pardoprunox

Drug: Pardoprunox

4

Placebo Comparator group

Treatment:

Drug: Placebo