The purpose of this study is to generate long-term safety, tolerability and efficacy data for AFQ056 in patients who have participated in and completed any AFQ056 phase II study in PD-LID (Parkinson's disease, L-dopa induced dyskinesias).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
66
Novartis Investigative Site
Sunnyvale, California, United States
Novartis Investigative Site
Incidence and severity of AEs/SAEs, changes in vital signs, lab assessments and ECGs, in cognitive function (MMSE), psychiatric symptoms (SCOPA-PC), and underlying symptoms of PD (UPDRS part III, CGIC, PGIC).
Time frame: 3.5 years
Assessment of dyskinetic symptoms by change from baseline in mAIMS total score
Time frame: 3.5 years
Investigator and patient assessment of clinical changes in dyskinetic symptoms and disability due to dyskinesia compared to baseline, as measured by the corresponding CGIC and PGIC items respectively
Time frame: 3.5 years
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Englewood, Colorado, United States
Novartis Investigative Site
Indianapolis, Indiana, United States
Novartis Investigative Site
Heidelberg, Victoria, Australia
Novartis Investigative Site
Parkville, Victoria, Australia
Novartis Investigative Site
Prahran, Victoria, Australia
Novartis Investigative Site
Ottawa, Ontario, Canada
Novartis Investigative Site
Gatineau, Quebec, Canada
Novartis Investigative Site
Greenfield Park, Quebec, Canada
Novartis Investigative Site
Clermont-Ferrand, France
...and 12 more locations