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Toxins 2018, 10(10), 401; https://doi.org/10.3390/toxins10100401

Botulinum Toxin in Restless Legs Syndrome—A Randomized Double-Blind Placebo-Controlled Crossover Study

1
Department of Neurology, Yale University School of Medicine, New Haven, CT 06510, USA
2
Department of Neurology, Columbia Asia Hospitals, Sarjapur Rd, Bangalore 560102, India
3
Department of Neurology, Mayo Clinic, Rochester, MN 55905, USA
4
Department of Neurology, Hartford Healthcare Ayer Neuroscience Institute, Hartford, CT 06066, USA
*
Author to whom correspondence should be addressed.
Received: 6 September 2018 / Revised: 27 September 2018 / Accepted: 27 September 2018 / Published: 29 September 2018
(This article belongs to the Special Issue Botulinum Toxin Treatment of Movement Disorders)
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Abstract

Background: Restless Legs Syndrome (RLS) is a common movement disorder with an estimated prevalence of up to 12%. Previous small studies with onabotulinumtoxin A (OnaA) for RLS have shown inconsistent results. Methods: Twenty-four patients with an International RLS score (IRLS) of >11 (moderate-severe) were enrolled in this blinded, placebo-controlled crossover study. Twenty-one patients completed the evaluations at 4, 6, and 8 weeks after each injection. One-hundred units of Incobotulinumtoxin A (IncoA) or normal saline were injected into tibialis anterior, gastrocnemius, and biceps femoris muscles each side. Results: Improvement from a severe (IRLS >21) to a mild/moderate (IRLS ≤20) score was significant at four weeks (p = 0.0036) and six weeks (p = 0.0325) following IncoA administration compared to placebo. Additionally, there was significant improvement in pain score at six weeks as measured by Visual Analogue Scale (p = 0.04) and the Johns Hopkins Quality of Life Questionnaire (p = 0.01) in the IncoA group. Definite or marked improvement on Patient Global Impression of Change was seen in 7 out of 21 patients in the IncoA group vs. 1 out of 21 patients in the placebo group at 4 weeks (p = 0.012). Conclusion: IncoA injection lead to a reduction in severity of RLS symptoms, pain score, and quality of life, without any adverse effects. View Full-Text
Keywords: incobotulinumtoxin A; restless legs syndrome; botulinum toxin; clinical trial; sleep; movement disorder incobotulinumtoxin A; restless legs syndrome; botulinum toxin; clinical trial; sleep; movement disorder
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Mittal, S.O.; Machado, D.; Richardson, D.; Dubey, D.; Jabbari, B. Botulinum Toxin in Restless Legs Syndrome—A Randomized Double-Blind Placebo-Controlled Crossover Study. Toxins 2018, 10, 401.

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