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Rotigotine for RLS

Clinical bottom line

There is insufficient evidence, from a single, short trial, to say that rotigotine is of any value in treating RLS.


Reference

K Stiasny-Kolster et al. Patch application of the dopamine agonist rotigotine to patients with moderate to advanced stages of restless legs syndrome: a double-blind, placebo-controlled pilot study. Movement Disorders, 2004 19: 1432-1438.

Clinical trial

The trial randomised people with moderate or worse symptoms of RLS to one-week of patches with rotigotine at three different doses, and placebo. RLS symptoms and sleep were measured using standard scales.

Results

Details of the trial are shown in Table 1. There were some statistically significant benefits of rotigotine at the highest dose over placebo for RLS symptoms.

Table 1: Clinical trial of rotigotine

Reference
Design
Treatments and Outcomes
Patient details
Efficacy
Adverse Events
Stiasny-Kolster et al. Mov Disord 2004 19: 1432-1438 R = 2
DB = 1
WD = 1
QS = 4
Parallel group
Duration = one week
Treatments
1 Rotigotine patches at 1.125, 2.25 or 4.5 mg daily (49)
2 Placebo patch (14)

Outcomes
Standard symptom questionnaires
Mean age 59 years, slightly over 50% women, duration of RLS about 10 years, most with moderate or worse severity Highest rotigotine dose produced significant improvement compared with placebo, with dose-response for improved symptoms No serious adverse events. Treatment-related AEs were slightly more frequent in the two higher doses than lower dose or placebo. About 30% has application site reactions.

 

Comment

This pilot study provides insufficient evidence for using rotigotine patches in RLS.