Evaluation of the Efficacy and Safety of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias

Novartis Pharmaceuticals78 enrolled

Overview

This study will assess the efficacy and safety of AFQ056 in patients that have Parkinson's Disease L-dopa Induced Dyskinesias (PD-LID)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Dyskinesias Parkinson Disease Movement Disorders Parkinsonian Disorders

Interventions

AFQ056DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Outpatients with Parkinson's disease (PD), treated with L-Dopa, experiencing dyskinesias for at least three months * Outpatients who are on a stable anti-parkinsonian treatment regimen for at least four weeks Exclusion Criteria: * Surgical treatment for PD * Cancer within the past 5 years (other than localized skin cancer and prostate cancer that has been effectively treated) * Advanced, severe or unstable disease (other than PD) or evidence of dementia that may interfere with the study outcome evaluations Other protocol-defined inclusion/exclusion criteria may apply

Locations (28)

Novartis Investigative Site

Sunnyvale, California, United States

Outcomes

Primary Outcomes

Anti-dyskinetic efficacy as measured by the modified AIMS (Abnormal Involuntary Movement Scale) total score. To assess how titration of AFQ056 at 2-week intervals affects tolerability profile

Time frame: 12 weeks

Secondary Outcomes

Anti-dyskinetic efficacy as measured by the Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS)

Time frame: 12 weeks

Change from baseline on patient's disability caused by the dyskinesia as assessed by a clinician-rated global impression of change (CGIC)

Time frame: 12 weeks

Total ON- and OFF-times and ON-time with dyskinesia and with troublesome dyskinesias (patient diary)

Time frame: 12 weeks

Anti-dyskinetic efficacy as measured by items 32, 33 and 34 of Part IV of the Unified Parkinson's Disease Rating Scale (UPDRS )

Time frame: 12 weeks

Safety of AFQ056 as measured by changes in vital signs, laboratory values, electrocardiogram and number of Adverse Events

Time frame: 12 weeks

Data from ClinicalTrials.gov

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