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Restless legs syndrome (RLS) is a highly prevalent sensorimotor disorder. Effective treatments for RLS have been established in large placebo-controlled trials. These trials have generally employed the International RLS Rating Scale (IRLS) (range 0–40)1 and Clinical Global Impression of Change (CGI). The interpretation of clinical trials has been mitigated by a large placebo response for both the IRLS and CGI.2 We wished to evaluate specific patient, scale, and trial design predictors of placebo response.
Footnotes
Supplemental data at www.neurology.org
Author contributions: William Ondo: all aspects of manuscript preparation. Md Monir Hossain, PhD: statistical analysis and critical review. Mark Forrest Gordon, MD: data acquisition, intellectual contribution, and critical review. Juergen Reess, MD: data acquisition, intellectual contribution, and critical review.
Study funding: No targeted funding reported.
Disclosure: W. Ondo has received speaker and consultant honoraria from TEVA, Allergan, Lundbeck, Merz, Ipsen, Novartis, and UCBPharma. M.M. Hossain: none. M.F. Gordon is a paid employee of Boehringer Ingelheim. J. Reess is a paid employee of Boehringer Ingelheim. Go to Neurology.org for full disclosures.
- Received November 1, 2012.
- Accepted in final form March 7, 2013.
- © 2013 American Academy of Neurology
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