Evaluation of the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease
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This phase IIb study is designed to determine the safe and efficacious dose or dose range of AFQ056 for the treatment of patients with moderate to severe Parkinson's disease with L-Dopa induced dyskinesias.
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
13-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
Study Start Date
Actual Primary Completion Date
Resource links provided by the National Library of Medicine
Change from baseline to endpoint in the modified AIMS (Abnormal Involuntary Movement Scale) total score [ Time Frame: 12 weeks ]
Secondary Outcome Measures
Disability due to dyskinesias as measured by change from baseline to endpoint in the PDYS-26 (26-Item Parkinson Disease Dyskinesia Scale) total score [ Time Frame: 12 weeks ]
Change from baseline on patient's dyskinesia, disability caused by the dyskinesia and the underlying symptoms of PD as assessed by a clinician-rated (CGIC) and a patient-rated (PGIC) global impression of change [ Time Frame: 12 weeks ]
Anti-dyskinetic efficacy as measured by items 32 and 33 of Part IV of the UPDRS (Unified Parkinson's Disease Rating Scale) [ Time Frame: 12 weeks ]
Worsening of underlying symptoms of PD as measured by: UPDRS Part III; patient diary (dyskinesias); patient/clinician assessments of change in PD symptoms; AEs related to worsening of PD [ Time Frame: 12 weeks ]
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Ages Eligible for Study:
30 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Outpatients with Parkinson's disease (PD), treated with L-Dopa, experiencing dyskinesias for at least three months
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) that may interfere with the study outcome evaluations
Other protocol-defined inclusion/exclusion criteria may apply