Abstract
Spasticity can be a very disabling problem in some amyotrophic lateral sclerosis (ALS) phenotypes, such as upper motor neuron-dominant ALS (UMN-D ALS) and primary lateral sclerosis (PLS). Our aim is to describe the safety and efficacy of botulinum toxin A (BoTox-A) for improving gait in those ALS phenotypes. UMN-D ALS and PLS outpatients experiencing gait disturbances, secondary to moderate-to-severe spasticity despite optimized oral medication, were offered BoTox-A treatment. Stretching exercises were indicated to complement BoTox-A effect, and ankle–foot orthotics were prescribed when appropriate. Tolerance (muscle strength, disease progression rate) and efficacy (10-m walk test) were measured at baseline and after treatment. Eight out of 122 ALS outpatients were offered BoTox-A treatment. One declined and the other seven were administered BoTox-A in the lower limbs, every 5–8 months. All of them experienced improvement in the clinical outcome and all but one referred subjective improvement. Moreover, after a median follow-up of 16 months and three injections, BoTox-A effect was maintained with no adverse events. This study provides class IV evidence that BoTox-A is safe , and could be beneficial in the short term and long term in a subset of ALS patients with moderate-to-severe spasticity.
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Acknowledgments
The authors thank Ignacio Dobón and Rosa Mª Vilar for their collaboration in patient recruitment. We also thank Victoria Fornés Ferrer for her help in graphics design.
Funding
The research leading to these results has received funding from Instituto de Investigación Sanitaria La Fe (2013/0332, PI Vázquez/Sevilla) and from Instituto de Salud Carlos III (ISCIII, PI12/0946, PI Sevilla). The Centro de Investigación Biomédica en Red de Enfermedades Raras (CIBERER) is an initiative from the ISCIII.
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The ethical committee for biomedical research of Hospital La Fe has approved this study. All participants gave their informed consent prior to their inclusion in the study.
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Vázquez-Costa, J.F., Máñez, I., Alabajos, A. et al. Safety and efficacy of botulinum toxin A for the treatment of spasticity in amyotrophic lateral sclerosis: results of a pilot study. J Neurol 263, 1954–1960 (2016). https://doi.org/10.1007/s00415-016-8223-z
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DOI: https://doi.org/10.1007/s00415-016-8223-z