Abstract Details

Title Determination of the Minimal Clinically Important Improvement in IRLS Total Score in Patients with Moderate to Severe Restless Legs Syndrome Treated with Rotigotine Transdermal System: A Post Hoc Analysis from a 6-Month Placebo-Controlled European Study

Topic Movement Disorders

Presentation(s) P02 - (-)

Poster/Presentation
Number 056

Objective

Background BACKGROUND: The 6-month randomized, double-blind, placebo-controlled European study (SP790; NCT00136045) established the efficacy of rotigotine vs placebo using the IRLS total score (primary endpoint) and CGI global change score (secondary endpoint). The mean (SD) change from baseline in rotigotine IRLS total score was: 1mg, -13.2 (10.0); 2 mg, -15.6 (9.5); 3 mg, -16.1 (10.9). The mean (SD) change from baseline in IRLS total score for placebo (n=101) was -8.0 (9.7).

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: 307 randomized patients receiving rotigotine with 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 -4.2 (7.0), -3.8 (5.4), -8.2 (6.7), -12.4 (7.2), and -22.8 (7.2), respectively; a 29.6% change in mean IRLS total score from baseline to EoM was consistent with minimal improvement. IRLS total scores generally improved from baseline with improvements in the CGI (r = 0.67). The MCIC ROC cut-off for IRLS total scores was -6 points (sensitivity = 0.69; specificity = 0.65).

Conclusions CONCLUSIONS: In patients with moderate to severe RLS, a 6 point reduction in the IRLS total score is felt to be clinically meaningful.

Authors/Disclosures
Ralf Kohnen, PhD, ScD (RPS Research Germany) PRESENTER	No disclosure on file
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
William Ondo, MD (Methodist Neurological Institute)	Dr. Ondo has received personal compensation in the range of $50,000-$99,999 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 $500-$4,999 for serving on a Speakers Bureau for Kyowa Kirin. The institution of Dr. Ondo has received research support from Cerevel. The institution of Dr. Ondo has received research support from SCION. The institution of Dr. Ondo has received research support from Harmony. Dr. Ondo has received publishing royalties from a publication relating to health care.
Giancarlo Comi, MD (University Vita-Salute)	Dr. Comi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Janssen. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bristol Myers Squibb. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Aspen Healthcare. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Sanofi. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Rewind.

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