Treatment of Upper Limb Spasticity after Stroke: One-Year Safety and Efficacy of Botulinum Toxin Type A NT201

Abstract

A new preparation of botulinum toxin type A called NT 201, free from complexing proteins, potentially with low antigenicity has been used in the therapy of spasticity in stroke patients. This was an open-label study reported the safety and the efficacy of one-year treatment with NT 201 evaluating the therapeutic effect on functional disability and on quality of life in upper limb spasticity after stroke. Patients received a botulinum toxin therapy in the upper injected intramuscularly. After inoculation, patients were submitted to a motor rehabilitation program for upper limb injected three times/week. Re-treatment was permitted at 12 weeks after the prior treatment. Safety assessment included evaluation of adverse events and efficacy was measured by Modified Ashworth Scale for spasticity (MAS), Spasm Frequency Score (SFS) for the daily spasms, and Disability Assessment Scale (DAS) for disability. Of 35 consecutive patients (13 women and 12 men) screened for study eligibility, 20 (6 women and 14 men) patients (mean age 63,4±7,03) were included in this study and were submitted to NT 201 therapy for one year. At the baseline, botulinum toxin dose in the upper limb ranged from 160 to 450U, whereas total dose in the last treatment administrated was reduced respect the first injections ranging from 120 to 350U. All the enrolled patients completed the year-long study and reported an improvement of clinical picture. MAS, was statistically (p<0,001) reduced in all muscles at T1 (mean score ±SD: 2.65±0.67) and T2 (mean score ±SD: 2.55±0.60) in comparison to the baseline T0 (mean score ±SD: 3.9±0.78). Significant reduction (p<0,001) from baseline T0 (mean score ±SD: 3.25± 0.78) was also noted in SFS at T1 (mean score ±SD: 1.55±0.51) and T2 (mean score ±SD: 1.30±0.47). The DAS score showed a reduction of the T1score (mean score ±SD: 1.70±0.47) and T2 score (mean score ±SD: 1,40±0,50) respect to baseline T0 score (mean score ±SD: 2,65±0,48) statistically significant (p<0,001). No adverse effects were observed in these patients. NT 201 appeared to be an efficacious and well-tolerated long-term treatment option for patients with upper limb spasticity after stroke, obtaining a substantial improvement in functional disability, muscle hypertone, and daily spasms.

Clinical and pharmacological properties of incobotulinumtoxinA and its use in neurological disorders

“…One of these studies explored the safety and efficacy of incobotulinumtoxinA in upper-limb post-stroke spasticity over a 1-year period in 20 patients who could receive retreatment every 12 weeks. 27 One year after the initial incobotulinumtoxinA treatment, muscle tone, determined using the MAS, was significantly reduced in all muscle groups treated ( P <0.001). In addition, DAS scores and daily spasm frequency were also significantly reduced ( P <0.001 for all).…”

Improvement in Disability Assessment Scale after Botulinum toxin A treatment for upper limb spasticity

“…Patients are evaluated in an interview format, enabling the severity of the disability to be assessed (Table 1). Most studies involving DAS evaluations before and after BoNT-A administration [4][5][6][7][8][9][10][11][12][13][14][15][16][17] have focused on one treatment target from among the four DAS parameters. Simpson et al [7] reported that DAS scores improved significantly 6 weeks after BoNT-A administration in 19 patients who chose limb position as the target out of a total of 60 cases.…”

Efectividad de la toxina botulínica en la parálisis cerebral infantil, patología adquirida y patología idiopática en la población infanto-juvenil de un servicio de rehabilitación

“…Ade-Hall en el 2000 realiza una revisión bibliográfica donde se aconseja el uso de toxina para el control de los espasmos y espasticidad en niños con parálisis cerebral 184 . También encontramos otros artículos donde se evidencia la mejoría de los espasmos diarios tras la aplicación de toxina tanto en extremidad inferior 199 cómo en superior tras daño cerebral adquirido 200 .…”