SLEEP 2011 Abstract Supplement

B. Clinical Sleep Science V. Sleep Disorders – Movement Disorders
0596
ONSET OF ACTION OF ROTIGOTINE TRANSDERMAL
SYSTEM IN THE TREATMENT OF RESTLESS LEGS
SYNDROME (RLS): A POST-HOC ANALYSIS OF DATA FROM
A 1-WEEK PILOT STUDY
Moran K 1 , Bogan R 2 , Stiasny-Kolster K 3 , Schollmayer E 4 , Bauer L 4 ,
Oertel W 3
1
UCB Pharma Inc, Smyrma, GA, USA, 2 SleepMed of South Carolina
Inc, Columbia, SC, USA, 3 Phillips-Universität, Marburg, Germany,
4
Schwarz Biosciences GmbH, a member of the UCB Group of
Companies, Monheim, Germany
Introduction: Placebo-controlled trials have demonstrated the efficacy
of rotigotine transdermal system in the treatment of moderate-to-severe
idiopathic RLS; however, rotigotine onset of action has not previously
been investigated. SP666 was a double-blind pilot study with rotigotine
in patients with RLS. In this post-hoc analysis, onset of action was
assessed using RLS symptom severity ratings following first patch application.
Methods: Patients received rotigotine (0.5, 1.0 or 2.0 mg/24h) or placebo
(n=17/13/19/14 respectively) for 1 week without titration, and recorded
their ratings of RLS symptom severity (0=no symptoms; 10=maximum
symptoms), sleep satisfaction (-3=very dissatisfied; 3=very satisfied)
and daytime sleepiness/tiredness (0=none to 10=maximum) in daily
diaries. The first post-treatment assessment (T1) was from diary entries
completed the morning after first dose of trial medication, ie ~12 hours
after first patch application.
Results: Baseline to T1 improvements were observed with rotigotine
versus placebo in severity of symptoms while falling asleep
(mean±standard deviation [SD] change from baseline: rotigotine,
-1.17±2.75, -1.15±2.72 and -1.92±3.39 points with 0.5, 1, and 2 mg/24
h respectively; 0.27±1.31 points with placebo), symptom severity during
the night (rotigotine, -1.37±3.83, -1.69±2.29 and -2.46±3.44 points;
placebo, -0.06±1.38 points), daytime symptom severity while resting
(rotigotine, -0.42±2.31, -0.36±1.52, and -1.4±2.59 points; placebo,
0.04±1.30 points), sleep satisfaction (0.84±2.51, 0.91±1.86 and
0.37±2.13 points; placebo, 0.28±1.03 points), and daytime sleepiness/
tiredness (rotigotine, 0.71±2.09, 0.28±1.39 and 0.98±1.93 points; placebo,
-0.38±1.20 points). As the first patch was applied in the evening and
T1 took place the following morning, no change in daytime symptom
severity can be expected.
Conclusion: Rotigotine showed a descriptive benefit versus placebo in
alleviating RLS symptoms at the first post-treatment timepoint assessed.
In this post-hoc assessment, statistical analysis was descriptive only, due
to low patient numbers; however, these results suggest an onset of action
of rotigotine within 1 day, and possibly within the first 12 hours after
initial patch application.
Support (If Any): UCB Pharma Inc, delegated by Schwarz Pharma Ltd,
Ireland
0597
EVALUATION OF THE ASSOCIATION BETWEEN THE
INTERNATIONAL RLS STUDY GROUP RATING SCALE
(IRLS) AND THE RESTLESS LEGS SYNDROME QUALITY OF
LIFE QUESTIONNAIRE (RLS QOL): A POST HOC ANALYSIS
OF A PHASE III ROTIGOTINE CLINICAL TRIAL
Allen RP 1 , Oertel W 2 , Walters AS 3 , Schollmayer E 4 , Grieger F 4 ,
Moran K 5 , Kohnen R 6,7
1
Johns Hopkins University, Baltimore, MD, USA, 2 Philipps-
Universität, Marburg, Germany, 3 Dept of Neurology, Vanderbilt
University School of Medicine, Nashville, TN, USA, 4 Schwarz
Biosciences GmbH, a member of the UCB Group of Companies,
Monheim, Germany, 5 UCB Pharma Inc, Smyrna, GA, USA,
6
University of Erlangen-Nuremberg, Nuremberg, Germany, 7 Research
Pharmaceutical Services Inc, Fort Washington, PA, USA
Introduction: The IRLS and RLS QoL are both validated, disease-specific
instruments for assessing disease severity and quality of life, respectively,
in patients with restless legs syndrome (RLS). To understand
how IRLS scores relate to meaningful benefits from the patient perspective,
we carried out a scale association analysis between the IRLS and
the 12-item RLS QoL (developed by R Kohnen).
Methods: In a Phase III, double-blind trial (SP790 [NCT00136045]),
patients with moderate-to-severe idiopathic RLS (IRLS ≥15) were randomized
to rotigotine transdermal system (1-3 mg/24h titrated to fixed
dose over 3 weeks, maintained at that dose for 6 months) or placebo.
Rotigotine-treated patients achieved significantly greater improvements
in IRLS score from baseline to end of maintenance (EoM), and quality
of life (as measured by mean changes in RLS QoL total score) improved
in a dose-dependent manner. Scale associations were analysed categorically
for IRLS and RLS QoL total scores, and as continuous variables,
using the safety set of rotigotine- and placebo-treated patients combined
(n=458).
Results: At baseline and EoM, categorical analysis showed a trend towards
higher RLS QoL scores (ie, worsening quality of life) with increasing
disease severity category on the IRLS. Mean baseline RLS QoL
scores were 19.71, 29.14 and 40.81 in IRLS categories 11-20, 21-30 and
31-40, respectively. Mean EoM RLS QoL scores were 7.66, 19.21, 29.91
and 43.92 in IRLS categories 0-10, 11-20, 21-30 and 31-40, respectively.
Pearson correlation coefficients at baseline (0.69; p