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

Solvay Pharmaceuticals

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Parkinson's Disease

Interventions

SLV308DRUG

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

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.

Locations (10)

Site 16

Plovdiv, Bulgaria

Site 11

Sofia, Bulgaria

Site 12

Sofia, Bulgaria

Site 13

Sofia, Bulgaria

Data from ClinicalTrials.gov

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