Efficacy and Safety of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Disease Patients, and Safety in Combination With L-dopa

Novartis31 enrolled

Overview

This study will evaluate the safety and efficacy of administration of AFQ056 in combination with L-dopa, in reducing the number of L-dopa related dyskinesias in Parkinson's disease patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Parkinson's Disease

Interventions

AFQ056DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 30 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with Parkinson's Disease * Patients with L-dopa induced dyskinesia for at least 3 months * Patients with L-dopa treatment for at least 3 years, stable for 1 month minimum Exclusion Criteria: * History of severe allergy to food or drugs * Very low or high body weight. * Prior surgery for Parkinson's Disease * Smokers Other protocol-defined inclusion/exclusion criteria may apply

Locations (5)

Novartis Investigator Site

Dresden, Germany

Novartis Investigator Site

Kassel, Germany

Novartis Investigator Site

Leun, Germany

Novartis Investigator Site

Marburg, Germany

Novartis Investigator Site

Outcomes

Primary Outcomes

Number and severity of Dyskinesias and the safety and tolerability of administering AFQ056 in combination with L-dopa

Time frame: throughout the study

Secondary Outcomes

Number and severity of Dyskinesias and the safety and tolerability of administering AFQ056 in combination with L-dopa

Time frame: throughout the study

Data from ClinicalTrials.gov

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