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

Novartis28 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

QUADRUPLE

Enrollment

Conditions

Parkinson's Disease L-dopa Induced Dyskinesia

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 Investigative Site

Dresden, Germany

Novartis Investigative Site

Kassel, Germany

Novartis Investigative Site

Leun-Biskirchen, Germany

Novartis Investigative Site

Marburg, Germany

Novartis Investigative Site

Outcomes

Primary Outcomes

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

Time frame: 20 days

Secondary Outcomes

Safety and tolerability of administration of AFQ056 in combination with L-dopa

Time frame: 20 days

Data from ClinicalTrials.gov

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