A Phase 2 interventional study of AFQ056 in Parkinson Disease, Dyskinesia, Drug-Induced and Levodopa, sponsored by Novartis Pharmaceuticals. Completed at 22 sites in 6 countries. Per ClinicalTrials.gov, last updated 2020-12-23.
Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment
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).
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 66 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Drug: AFQ056
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
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals