Session Information
Date: Sunday, October 7, 2018
Session Title: Restless Legs Syndrome and Other Sleep Disorders
Session Time: 1:45pm-3:15pm
Location: Hall 3FG
Objective: To study the efficacy of incobotulinumtoxin A (IncoA) in relieving the symptoms of restless legs syndrome (RLS)
Background: RLS is a common movement disorder with an estimated prevalence of up to 15%. Previous small studies with onabotululinumtoxin A in RLS have shown mixed results.
Methods: Twenty-four patients with International RLS score (IRLS) of > 11 (moderate-severe) were enrolled in this blinded, placebo-controlled cross-over study. Twenty-one patients completed the evaluations at 4, 6 and 8 weeks after each injection. IncoA (100-120U) or normal saline was injected into tibialis anterior, gastrocnemius and hamstring muscles per side. Wilcoxon signed rank and Fischer exact test were utilized to compare continuous and nominal variables, respectively.
Results: Improvement from severe (IRLS >21) to either mild/moderate (IRLS ≤20) score was significant at 4 weeks (p=0.0036) and 6 weeks (p=0.0325) following IncoA administration compared to placebo. No significant improvement was detected at 8 weeks (p=0.0670). Additionally, there was a significant improvement in pain score by Visual Analogue Scale at 6 weeks (p=0.04) and John Hopkins quality of life at 6 weeks (p=0.01) in the study group. Definite or marked improvement in the patient global impression of change was seen in 7 IncoA patients versus 1 patient in the placebo group at 4 weeks (p=0.012). Epworth sleepiness scale and sleep questionnaire on medical outcome study were not significantly different between study and placebo groups.
Conclusions: IncoA injection leads to a short-term reduction in severity of RLS symptoms (IRLS rating scale), pain score and quality of life, without any significant adverse effects. This was presented as a poster at American Academy of Neurology (AAN 2017) and platform at Movement Disorder Society of India Conference (MDSICON 2018).
References: P. Agarwal, C. Sia, N. Vaish, I. Roy-Faderman, Pilot trial of onabotulinumtoxina (Botox) in moderate to severe restless legs syndrome, Int J Neurosci. 121 (2011) 622-625. F.B. Nahab, E.L. Peckham, M. Hallett, Double-blind, placebo-controlled, pilot trial of botulinum toxin A in restless legs syndrome, Neurology. 71 (2008) 950-951.
To cite this abstract in AMA style:
S. Mittal, D. Machado, D. RIchardson, D. Dubey, B. Jabbari. Botulinum toxin in Restless Leg Syndrome – A Randomized Double-Blind Placebo-Controlled Study [abstract]. Mov Disord. 2018; 33 (suppl 2). https://www.mdsabstracts.org/abstract/botulinum-toxin-in-restless-leg-syndrome-a-randomized-double-blind-placebo-controlled-study/. Accessed June 5, 2025.« Back to 2018 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/botulinum-toxin-in-restless-leg-syndrome-a-randomized-double-blind-placebo-controlled-study/