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

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

Official Title
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12-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease

Conditions
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Parkinson Disease, Dyskinesias, Movement Disorders, Parkinsonian Disorders

Intervention / Treatment
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* Drug: AFQ056
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AFQ056 100 mg<br> | Drug: AFQ056<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-dyskinetic efficacy as measured by the Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS) |  | 12 weeks | 
| Change from baseline on patient's disability caused by the dyskinesia as assessed by a clinician-rated global impression of change (CGIC) |  | 12 weeks | 
| Total ON- and OFF-times and ON-time with dyskinesia and with troublesome dyskinesias (patient diary) |  | 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 ) |  | 12 weeks | 
| Safety of AFQ056 as measured by changes in vital signs, laboratory values, electrocardiogram and number of Adverse Events |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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L-dopa, Levodopa, Parkinson Disease, Dyskinesia, Anti-Dyskinesia Agents