“Appropriate Treatment” and Therapeutic Window in Spasticity Treatment with IncobotulinumtoxinA: From 100 to 1000 Units (original) (raw)
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Botulinum toxin A in the treatment of spasticity – An open label study
Journal of Back and Musculoskeletal Rehabilitation, 2002
To assess the efficacy of botulinum toxin type A in spasticity in upper-motor neuron syndromes. Methods: Twenty-three patients with spasticity resulted from stroke-related hemiplegia, transverse myelitis and multiple sclerosis took part in the study. Following the history and physical examinations of the patients, injections of botulinum toxin-A were applied. The dose ranged from 80 to 400 mouse unit (MU) depending on the size of the muscle injected. In all patients, spasticity, spasms and pain were measured using the Ashworth Scale, Spasm Frequency Score, and Visual Analogue Scale prior to the therapy, at the 1st week, 1st month and 3rd month of the therapy. Results: In all patients, botulinum toxin type A led to a significant decrease in spasticity, spasms and pain after the 1st week, 1st and 3 rd months of the treatment when compared to the baseline values (p < 0.001). No significant side effects or complications were observed. Conclusion: Our results have demonstrated that botulinum toxin type A is effective in the management of patients with spasticity due to stroke-related hemiplegia, transverse myelitis and multiple sclerosis, without major adverse effects.
Effect of botulinum toxin type-A in patients with focal spasticity
Northern Clinics of Istanbul, 2015
OBJECTIVE: To investigate the effect of botulinum toxin type-A (BTX-A) on spasticity and function in patients with focal spasticity. METHODS: Patients attended to the outpatient clinic of physical medicine and rehabilitation department with a diagnosis of focal spasticity and had BTX-A injections because of spasticty were evaluated for the study. Demographic data, exercise status, orthoses, drugs used for spasticity, functional status, stages of spasticity of muscles before and after 1 st and 3 rd months of BTX-A injection according to Modified Ashworth Scale (MAS) were evaluated retrospectively. MedCalc 11.6 statistical program was used for statistical analyses. Statistical significance was defined as p<0.05. RESULTS: Forty-nine patients with focal spasticity were recruited for the study (35 men, 14 women). Mean age of the patients was 21.59±20.09 years. The patients had cerebral palsy (CP, n=28), 19 had hemiplegia (n=19) and paraplegia (n=2). Forty-three patients were using orthoses and exercising regularly. Mean Pediatric Functional Independence Measurement (WeeFIM) scores of the patients with CP was 54.82±28.91 and according to the Gross Motor Function Classification System (GMFCS) the patients were in stages 2 (14%), 3 (46%), 4 (11%) and 5 (29%). Mean Functional Independence Measure (FIM) of hemiplegic and paraplegic patients was 80.80±20.88. Brunnstrom staging scores for upper extremity (3.52±0.96), hands (2.68±0.82), lower extremity (4.57±1.01) were calculated. MAS muscles demonstrated statistically significant decrease in spasticity at the end of first and third months (p<0.05). CONCLUSION: We saw a significant decrease in the spasticity of upper and lower extremities in patients with focal spasiticity who received BTX-A injections. We suggest that if BTX-A injections are supported with orthoses and exercise programs, then functional status of the patients would be better.
Journal of Rehabilitation Medicine, 2011
To investigate the efficacy and safety of repeated treatment with incobotulinum toxin A (botulinum neurotoxin type A free from complexing proteins; NT 201) in poststroke upper limb spasticity. Patients and design: After completing a double-blind, placebocontrolled, multicentre study (up to 20 weeks), 145 patients received up to 5 additional sets of NT 201 injections for an open-label extension period of up to 69 weeks. Methods: Upper limb muscle groups were treated as clinically indicated; injection intervals were ≥ 12 weeks. Outcome was assessed 4 weeks after each injection session and at the end of the study. Results: Muscle tone (flexors of wrist, elbow, finger, and thumb, and forearm pronators) improved throughout the study (response rate: up to 80.6%, p < 0.0001, Ashworth Scale). Continuous and significant improvements were also observed in disability (p < 0.05, Disability Assessment Scale). The majority of investigators, patients and caregivers rated NT 201 efficacy as very good or good (56-84%). Adverse events considered treatment-related occurred in 11% of patients. Formation of neutralizing antibodies was not observed in any patient after repeated treatments. Conclusion: Treatment with NT 201 showed sustained improvements in muscle tone and functionality (median dose 400 units) over a study duration of up to 89 weeks, and was well tolerated during repeated treatments for post-stroke upper limb spasticity.
Treatment of spasticity with botulinum toxin: A double-blind study
Annals of Neurology, 1990
We studied the effect of botulinum-A toxin on spasticity of the leg adductors in 9 patients who were either chairbound or bed-bound with chronic stable multiple sclerosis. We injected botulinum toxin (400 mouse units) or placebo into the adductor muscles in a randomized, crossover, double-blind design. Two physicians, who were unaware of the treatment order, used an objective rating scale and independently assessed the patients; interobserver correlation was excellent (r = 0.93-0.81). We found that botulinum toxin produced a significant reduction in spasticity ( p = 0.009) and a significant improvement in the ease of nursing care ($ = 0.009). There were no adverse effects during this shortterm trial. This is the first demonstration of the beneficial effect of botulinum toxin on focal spastic muscle contractions.
Archives of Physical Medicine and Rehabilitation, 2008
Elovic EP, Brashear A, Kaelin D, Liu J, Millis SR, Barron R, Turkel C. Repeated treatments with botulinum toxin type A produce sustained decreases in the limitations associated with focal upper-limb poststroke spasticity for caregivers and patients. Arch Phys Med Rehabil 2008;89:799-806. Objective: To assess the safety and evaluate the effects of repeated treatments with botulinum toxin type A (BTX-A) on functional disability, quality of life (QOL), and muscle tone of patients with upper-limb poststroke spasticity, as well as its effect on caregivers. Design: Multicenter, open-label, repeated-dose study. Setting: Thirty-five clinical sites in North America. Participants: Patients (Nϭ279) with upper-limb poststroke spasticity at 6 months or more poststroke.
BMJ Open, 2019
ObjectivesThe therapeutic effects of botulinum neurotoxin (BoNT) are well documented in upper limb spasticity. However, several factors may influence treatment efficacy, including targeting of neuromuscular junctions (NMJs). We examined whether NMJ-targeted BoNT injections were non-inferior, in terms of efficacy, to current injection practices.DesignOpen-label prospective evaluator-blinded study.SettingConducted across 20 medical centres in Denmark, Finland, Norway and Sweden (24 September 2012 to 11 March 2015).ParticipantsAged ˃18 years with upper limb spasticity (Modified Ashworth Scale [MAS] score of 2 or 3) following stroke or traumatic brain injury, had received ≥2 consecutive BoNT-A treatment cycles (the latest of which was abobotulinumtoxinA [aboBoNT-A]) and needed BoNT-A retreatment (same modality as previous cycle). Patients requiring aboBoNT-A doses >800units were excluded. In total, 88 patients were randomised (intention-to-treat [ITT] population), most were male (n=5...