Abstract Details

Title Minimal Clinically Important Improvement in IRLS Total Score in Patients with Restless Legs Syndrome: A Post Hoc Analysis from a 6-Month Placebo-Controlled US-Based Study with Rotigotine Transdermal System

Topic Movement Disorders

Presentation(s) P02 - (-)

Poster/Presentation
Number 059

Objective

Background BACKGROUND: The 6-month randomized, double-blind, placebo-controlled US study (SP792; NCT00135993) established the efficacy of rotigotine vs placebo using the IRLS (primary endpoint) and CGI global change scales. The mean (SD) change from baseline in rotigotine IRLS total score was: 0.5 mg, -10.9 (8.9); 1mg, -11.1 (9.3); 2 mg, -13.4 (9.2); 3 mg, -14.3 (9.4). The mean (SD) change from baseline in IRLS total for placebo (n=99) score was -9.0 (7.7).

Design/Methods DESIGN/METHODS: Patients diagnosed with moderate to severe idiopathic RLS were randomized to receive rotigotine or placebo. Mean changes (SD) from baseline to end of maintenance (EoM) in IRLS total score were calculated for each CGI score. Pearson's correlation coefficients evaluated the relationship between CGI and changes in the IRLS total scores at EoM. An anchor-based approach and receiver operating characteristic (ROC) curves determined the MCIC for the IRLS total score based on CGI scores using the full analysis set (without LOCF).

Results RESULTS: 322 randomized patients receiving rotigotine having baseline and EoM IRLS and CGI scores were included in the analysis. The mean (SD) change from baseline to EoM in IRLS total score in the CGI categories of 'minimally worse', 'no change', 'minimally improved', 'much improved', or 'very much improved' was 2.8 (6.6), -2.2 (4.7), -6.6 (6.1), -12.1 (6.1), and -18.4 (7.2) respectively; a 28.2% change in mean IRLS total score from baseline to EoM was consistent with minimal improvement. IRLS total score improvements from baseline to EoM increased with increasing CGI scores (r=0.72). The IRLS total score MCIC ROC cut-off was determined to be -5 (sensitivity = 0.7; specificity = 0.73).

Conclusions CONCLUSIONS: In patients with moderate to severe RLS, a 5 point reduction in IRLS total score is felt to be clinically meaningful.

Authors/Disclosures
William Ondo, MD (Methodist Neurological Institute) PRESENTER	Dr. Ondo has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for TEVA. Dr. Ondo has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Supernus. Dr. Ondo has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amneal. Dr. Ondo has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbvie. Dr. Ondo has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ACADIA. Dr. Ondo has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Neurocrine. Dr. Ondo has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for ACADIA. Dr. Ondo has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Abbvie. Dr. Ondo has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for TEVA. The institution of Dr. Ondo has received research support from Fascicle. The institution of Dr. Ondo has received research support from Cerevance. The institution of Dr. Ondo has received research support from AskBio. Dr. Ondo has received publishing royalties from a publication relating to health care.
Thomas Roth, PhD (Henry Ford Hospital)	Dr. Roth has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Takeda. Dr. Roth has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Avadel. Dr. Roth has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Jazz.
	No disclosure on file
Kimberly Moran, PhD (UCB)	No disclosure on file
Ralf Kohnen, PhD, ScD (RPS Research Germany)	No disclosure on file
Steven Galetta, MD, FAAN (NYU Langone Medical Center)	Dr. Galetta has nothing to disclose.