Clinical Trial: Open Label, Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Open-label Treatment Study to Evaluate the Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias
Brief Summary: 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).
Detailed Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Novartis
Dates:
Date Received: July 28, 2010
Date Started: October 2010
Date Completion:
Last Updated: March 17, 2017
Last Verified: March 2017
