Rotigotine Patch Provides Long-Term Relief for RLS

Author: UCB
Published: 2010/04/14 - Updated: 2025/05/27
Publication Details: Peer-Reviewed, Research, Study, Analysis
Category Topic: Restless Legs Syndrome (RLS) - Academic Publications

Page Content: Synopsis - Introduction - Main - Insights, Updates

Synopsis: This paper presents peer-reviewed, long-term clinical research on the use of rotigotine for treating moderate to severe Restless Legs Syndrome (RLS), a neurological condition marked by uncomfortable leg sensations and an urge to move, which affects up to 10% of the population. The study is notable for being the longest open-label, prospective follow-up of a placebo-controlled phase II RLS trial, tracking patients over five years and confirming both the safety and sustained efficacy of rotigotine.

Results showed that after five years, over a third of participants remained symptom-free, with significant and stable improvements in the International Restless Legs Syndrome Study Group Rating Scale (IRLS) and quality of life measures. The most common side effects were mild to moderate, including skin reactions, nasopharyngitis, and nausea, though 30% discontinued due to adverse events.

This information is authoritative and valuable for patients, caregivers, seniors, and people with disabilities seeking evidence-based, long-term treatment options for RLS, as it provides robust data on symptom control and quality of life improvements - Disabled World (DW).

Defining Restless Legs Syndrome

Restless Legs Syndrome: Restless Legs Syndrome (RLS) is a neurological disorder characterized by unpleasant sensations in the legs and an uncontrollable urge to move when at rest in order to relieve these feelings. It effects between 3 and 10% of the population to some extent. Some researchers estimate that RLS affects as many as 12 million Americans. However, others estimate a much higher occurrence because RLS is thought to be under-diagnosed and in some cases mis-diagnosed. Most people with RLS have difficulty falling asleep and staying asleep. Left untreated the condition causes exhaustion and daytime fatigue. Many people with RLS report that their job, personal relations and activities of daily living are strongly affected as a result of their exhaustion. They are often unable to concentrate, have impaired memory, or fail to accomplish daily tasks. More than 80% of people with RLS also experience a more common condition known as periodic limb movement disorder (PLMD).

Introduction

New data presented at the 62nd American Academy of Neurology annual meeting in Toronto, Canada, showed that patients with moderate to severe Restless Legs Syndrome (RLS) using rotigotine achieved sustained improvements in symptoms over 5 years of treatment.

"Many people with RLS will have spent months or years trying to get a diagnosis and find a treatment that can help them. So these 5-year results provide additional evidence that, once they start using rotigotine, people with RLS may experience long term relief from their symptoms, and a significant proportion may become symptom free," said Diego Garcia-Borreguero, MD, Director Sleep Research Institute, Madrid, Spain.

Main Content

This study of rotigotine in patients with moderate to severe RLS was the longest ever open label prospective follow-up of a placebo-controlled phase II trial in RLS. The final 5-year results confirm the safety and efficacy of rotigotine seen at previous interim analyses, with over a third of patients followed up remaining symptom free after 5 years of treatment.

Of the 295 patients with moderate to severe RLS who entered the study, 126 (43%) completed the 5-year follow up. The mean dose of rotigotine was 2.43 mg/24 hours after initial titration and 3.09 mg/24 hours at the end of the study. Fifty nine percent of patients were classified as remitters (IRLS less than or equal to 10), and 39% as symptom-free (IRLS=0).

The study looked at improvement in symptoms based on the International Restless Legs Syndrome Study Group Rating Scale (IRLS). The total IRLS score ranges from 0 (no symptoms) to 40 (very severe symptoms). A score of >20 indicates severe RLS. The mean IRLS score was 27.8 at baseline, improving by 18.7 points to 9.0 at the end of the study. Sustained improvements were also seen in quality of life and other RLS rating scales.

Most adverse events (AEs) were mild to moderate in intensity, the most common AEs being application site reactions (58%), nasopharyngitis (19%), back pain (14%), nausea (12%) and fatigue (11%). Thirty percent of patients discontinued the study due to an AE.

A comparison of 1, 2 and 5-year efficacy data (with 220, 191 and 126 patients respectively) showed that improvements in RLS symptoms remained stable throughout the follow-up period. Improvements in IRLS scores were 17.4 points at 1 year, 17.2 points at 2 years, and 18.7 points at 5 years.

The International Restless Legs Syndrome Study Group Rating Scale (IRLS) is a 10-item scale developed and validated by The International Restless Legs Syndrome Study Group and considered to be the best scale for evaluating the severity and frequency of RLS symptoms and the degree to which they affect sleep and daily life. It is administered by clinicians and includes questions related to the severity of sensory and motor symptoms, sleep disturbance, daytime somnolence and impact of RLS on activities of daily living and mood.

Insights, Analysis, and Developments

Editorial Note: The enduring effectiveness of rotigotine demonstrated in this research offers hope to those with persistent RLS symptoms, especially individuals who have struggled to find lasting relief. By documenting both the benefits and the risks, the study equips patients and healthcare providers with essential information for making informed decisions about long-term management of this challenging condition - Disabled World (DW).

Attribution/Source(s): This peer reviewed publication was selected for publishing by the editors of Disabled World (DW) due to its relevance to the disability community. Originally authored by UCB and published on 2010/04/14, this content may have been edited for style, clarity, or brevity.