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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
260
Change from baseline to endpoint in the modified AIMS (Abnormal Involuntary Movement Scale) total score
Time frame: 12 weeks
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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Novartis Investigative Site
East Gosford, Australia
Novartis Investigative Site
Heidelberg, Australia
Novartis Investigative Site
Melbourne, Australia
Novartis Investigative Site
Parkville, Australia
Novartis Investigational Site
Westmead, Australia
Quebec Memory & Motor Skills Disorders Clinic
Québec, Quebec, Canada
Clinique Neuro-Outaouais
Gatineau, Canada
Recherches Pembina, Inc
Greenfield Park, Canada
Novartis Investigative Site
Montreal, Canada
Parkinson's and Neurodegenerative Disorders Clinic
Ottawa, Canada
...and 37 more locations