Funding agencies: This study was funded by Novartis Pharma AG (Basel, Switzerland)
AFQ056 in Parkinson patients with levodopa-induced dyskinesia: 13-week, randomized, dose-finding study
Version of Record online: 12 JUL 2013
© 2013 Movement Disorder Society
Volume 28, Issue 13, pages 1838–1846, November 2013
How to Cite
Stocchi, F., Rascol, O., Destee, A., Hattori, N., Hauser, R. A., Lang, A. E., Poewe, W., Stacy, M., Tolosa, E., Gao, H., Nagel, J., Merschhemke, M., Graf, A., Kenney, C. and Trenkwalder, C. (2013), AFQ056 in Parkinson patients with levodopa-induced dyskinesia: 13-week, randomized, dose-finding study. Mov. Disord., 28: 1838–1846. doi: 10.1002/mds.25561
This study is registered (NCT00986414).
Relevant conflicts of interest/financial disclosures: Haitao Gao and Christopher Kenney are employees of Novartis Pharmaceuticals Corporation. Jennifer Nagel, Martin Merschhemke, and Ana Graf are employees of Novartis Pharma AG. Fabrizio Stocchi, Olivier Rascol, Alain Destee, Robert A. Hauser, Mark Stacy, and Claudia Trenkwalder have served on AFQ056 advisory board(s). Alain Destee received honoraria for consultancy from Novartis in the context of Clinical Drug development programs for Parkinson's disease. Werner Poewe has received honoraria for consultancy and lecture fees from Novartis AG in the context of clinical drug development programs for Parkinson's disease.
Mark Stacy Received Grant/Research Support from Ceregene, Michael J. Fox Foundation, NIH, Parkinson Study Group and has served as a consultant for Consultant Allergan, Biotie, Chelsea, General Electric, Johnson & Johnson, Lilly, Merz, Neuronova, Novartis, Osmotica, SK Life Sciences, UCB.
Full financial disclosures and author roles may be found in the online version of this article.
- Issue online: 13 NOV 2013
- Version of Record online: 12 JUL 2013
- Manuscript Accepted: 9 MAY 2013
- Manuscript Revised: 2 MAY 2013
- Manuscript Received: 2 NOV 2012
- Novartis Pharma AG (Basel, Switzerland). Grant Number: NCT00986414
Additional Supporting Information may be found in the online version of this article.
|mds25561-sup-0001-suppfig1.eps||1421K||SUPPORTING FIG. 1. The study design is illustrated. Enrolled patients were randomized to receive 20 mg/day, 50 mg/day, 100 mg/day, 150 mg/day, or 200 mg/day AFQ056 or placebo (1:1:1:1:2:3 ratio) in a 12-week, double-blind treatment phase. Patients were titrated at 1-week intervals to their target or highest tolerated dose. With the exception of the 20 mg/day AFQ056 group, all active-treated patients were initiated on 50 mg/day AFQ056. At the beginning of week 13, active-treated patients were randomized to a 1-week taper-off regimen with AFQ056 or placebo. The 20 mg/day AFQ056 group received 20 mg/day AFQ056 or placebo for 1 week, and the 50 mg/day AFQ056 group received 50 mg/day AFQ056 or placebo for 1 week. The 100 mg/day, 150 mg/day, and 200 mg/day AFQ056 groups received either 100 mg/day AFQ056 for 3 days followed by 50 mg/day AFQ056 for 4 days (1 week total duration) or placebo for 1 week.|
|mds25561-sup-0002-supptab1.doc||32K||Supporting Table 1. Summary of the final actual dose of AFQ056 received at the end of the treatment phase, by randomized dose|
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