Ascending Dose Tolerability/Safety of SLV308 for the Treatment of Parkinson's Disease

Solvay

Status and phase: Completed; Phase 3

Conditions: Parkinson's Disease

Treatments: Drug: SLV308

Study type: Interventional

Funder types: Industry

Identifiers

NCT00134251

S308.3.005

EuDract no 2005-002432-10

Details and patient eligibility

About

This study is a multicenter, randomized, double-blind, placebo controlled, parallel group study of a seven-week ascending dose period of SLV308 adjunctive to L-dopa treatment in patients with advanced stage Parkinson's disease (PD) and dose-dependent motor fluctuations. Patients (outpatients) will be randomized to one of three different treatment arms.

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have signed an informed consent; diagnosis of idiopathic PD.
• Presence of recognizable "on" and "off" stages
• Minimum hours of "off" time per day of 2.5 hours
• Able to keep diaries.

Exclusion criteria

• Unclear diagnosis or a suspicion of other parkinsonian syndromes
• Have undergone surgical treatment for PD
• History of non-response to L-dopa.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind