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Rotigotine improves restless legs syndrome: A 6‐month randomized, double‐blind, placebo‐controlled trial in the United States
Rotigotine helps restless legs syndrome in a 6-month controlled study in the US
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Abstract
A total of 505 participants showed significant improvements in restless legs syndrome symptoms with 2 to 3 mg/24 hr rotigotine compared to placebo.
- The IRLS sum score decreased significantly from baseline to the end of the 6-month period for participants receiving rotigotine.
- Rotigotine at doses of 2 mg/24 hr and 3 mg/24 hr was superior to placebo, with adjusted treatment differences of -4.5 and -5.2, respectively.
- Clinical global impressions also improved significantly, with adjusted differences of -0.65 for 2 mg/24 hr and -0.9 for 3 mg/24 hr compared to placebo.
- Mild to moderate skin reactions occurred in 27% of rotigotine subjects, while known side effects included nausea (18.1%) and headache (11.6%).
- Efficacy of rotigotine was maintained throughout the entire 6-month double-blind trial.
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