SLV308 for Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations

Solvay

Status and phase: Completed; Phase 3

Conditions: Advanced Stage Parkinson's Disease

Treatments: Drug: Levodopa (Pardoprunox); Drug: Placebo Comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT00406588

2006-005182-20

S308.3.002

Details and patient eligibility

About

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 extension to this study is planned as a separate protocol for patients who are willing and eligible to participate.

Enrollment: 295 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• '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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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295 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Levodopa (Pardoprunox)

2

Placebo Comparator group

Treatment:

Drug: Placebo Comparator