title: Safety and efficacy of botulinum toxin A for the treatment of spasticity in amyotrophic lateral sclerosis: results of a pilot study.
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.
authors.affiliation: Neuromuscular Research Unit, Instituto de Investigación Sanitaria la Fe (IIS La Fe), Valencia, Spain. juan.vazquez.neuro@gmail.com.|ALS Unit, Department of Neurology, Hospital Universitario y Politécnico La Fe, Avenida Fernando Abril Martorell 106, 46026, Valencia, Spain. juan.vazquez.neuro@gmail.com.|Centro de Investigación Biomédica en Red de Enfermedades Raras (CIBERER), Valencia, Spain. juan.vazquez.neuro@gmail.com.
authors.forename: Juan F
authors.identifier: http://orcid.org/0000-0002-3043-7938
authors.initials: JF
authors.lastname: Vázquez-Costa
authors.affiliation: ALS Unit, Department of Rehabilitation, Hospital Universitario y Politécnico La Fe, Valencia, Spain.
authors.forename: Inmaculada
authors.initials: I
authors.lastname: Máñez
authors.affiliation: ALS Unit, Department of Rehabilitation, Hospital Universitario y Politécnico La Fe, Valencia, Spain.
authors.forename: Ana
authors.initials: A
authors.lastname: Alabajos
authors.affiliation: ALS Unit, Department of Rehabilitation, Hospital Universitario y Politécnico La Fe, Valencia, Spain.
authors.forename: Maricruz
authors.initials: M
authors.lastname: Guevara Salazar
authors.affiliation: ALS Unit, Department of Rehabilitation, Hospital Universitario y Politécnico La Fe, Valencia, Spain.
authors.forename: Cristina
authors.initials: C
authors.lastname: Roda
authors.affiliation: Neuromuscular Research Unit, Instituto de Investigación Sanitaria la Fe (IIS La Fe), Valencia, Spain.|ALS Unit, Department of Neurology, Hospital Universitario y Politécnico La Fe, Avenida Fernando Abril Martorell 106, 46026, Valencia, Spain.|Centro de Investigación Biomédica en Red de Enfermedades Raras (CIBERER), Valencia, Spain.|Department of Medicine, University of Valencia, Valencia, Spain.
authors.forename: Teresa
authors.initials: T
authors.lastname: Sevilla
mesh_terms: D000328:Adult; D000368:Aged; D000690:Amyotrophic Lateral Sclerosis / Q000150:complications* / Q000188:drug therapy; D019274:Botulinum Toxins, Type A / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009128:Muscle Spasticity / Q000188:drug therapy* / Q000209:etiology*; D009465:Neuromuscular Agents / Q000627:therapeutic use*; D010865:Pilot Projects; D012189:Retrospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A
keywords: Amyotrophic lateral sclerosis; Botulinum toxin; Primary lateral sclerosis; Spasticity