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Safety and efficacy of incobotulinum toxin type A (NT 201-Xeomin) for the treatment of post-stroke lower limb spasticity: a prospective open-label study.
Eur J Phys Rehabil Med. 2013 Aug; 49(4):483-9.EJ

Abstract

BACKGROUND

In recent years, NT 201, a new botulinum toxin type A (BTX-A) free of complexing proteins, has been used for treating several movement disorders, showing safety and efficacy in upper limb spasticity.

AIM

To assess the safety and evaluate the effects of BTX-A NT 201 free from complexing proteins for the treatment of post-stroke lower limb spasticity evaluating spasticity grade, passive ankle dorsi-flexion motion, and muscle's spasms, as well as its efficacy and rate of satisfaction for patients and for the physicians.

DESIGN

Prospective open-label study.

POPULATION

Patients (71) with post-stroke lower limb spasticity at least 5 months by the event.

METHODS

Intramuscular injections of BTX-A NT 201 in soleus, medial, and lateral gastrocnemius with a maximum total dose of 180 U. Each patients was assessed at baseline, 30, and 90 days after treatment using Modified Ashworth Scale, Spasm Frequency Scale, evaluating passive ankle dorsi-flexion motion, and the rate of satisfaction for patients and investigators.

RESULTS

Patients treated with BTX-A NT 201 reported a statistically significant reduction in muscle tone and spasms daily increasing passive ankle dorsi-flexion at 30 days, persisting also at 90 days of follow-up.

CONCLUSION

BTX-A NT 201 for the treatment of post-stroke lower limb spasticity was safe and efficacious reducing muscle tone and spasms, and improving passive ankle dorsi-flexion movement.

CLINICAL REHABILITATION IMPACT

These results confirmed the safety and effectiveness of a new type of BTX-A, with low immunogenity, useful to improve rehabilitative treatment of post-stroke lower limb spasticity.

Authors+Show Affiliations

Department of Physical Medicine and Rehabilitation OORR Hospital, University of Foggia, Foggia, Italy - a.santamato@unifg.it.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

23480980

Citation

Santamato, A, et al. "Safety and Efficacy of Incobotulinum Toxin Type a (NT 201-Xeomin) for the Treatment of Post-stroke Lower Limb Spasticity: a Prospective Open-label Study." European Journal of Physical and Rehabilitation Medicine, vol. 49, no. 4, 2013, pp. 483-9.
Santamato A, Micello MF, Panza F, et al. Safety and efficacy of incobotulinum toxin type A (NT 201-Xeomin) for the treatment of post-stroke lower limb spasticity: a prospective open-label study. Eur J Phys Rehabil Med. 2013;49(4):483-9.
Santamato, A., Micello, M. F., Panza, F., Fortunato, F., Pilotto, A., Giustini, A., Testa, A., Fiore, P., Ranieri, M., & Spidalieri, R. (2013). Safety and efficacy of incobotulinum toxin type A (NT 201-Xeomin) for the treatment of post-stroke lower limb spasticity: a prospective open-label study. European Journal of Physical and Rehabilitation Medicine, 49(4), 483-9.
Santamato A, et al. Safety and Efficacy of Incobotulinum Toxin Type a (NT 201-Xeomin) for the Treatment of Post-stroke Lower Limb Spasticity: a Prospective Open-label Study. Eur J Phys Rehabil Med. 2013;49(4):483-9. PubMed PMID: 23480980.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and efficacy of incobotulinum toxin type A (NT 201-Xeomin) for the treatment of post-stroke lower limb spasticity: a prospective open-label study. AU - Santamato,A, AU - Micello,M F, AU - Panza,F, AU - Fortunato,F, AU - Pilotto,A, AU - Giustini,A, AU - Testa,A, AU - Fiore,P, AU - Ranieri,M, AU - Spidalieri,R, Y1 - 2013/03/13/ PY - 2013/3/14/entrez PY - 2013/3/14/pubmed PY - 2014/5/29/medline SP - 483 EP - 9 JF - European journal of physical and rehabilitation medicine JO - Eur J Phys Rehabil Med VL - 49 IS - 4 N2 - BACKGROUND: In recent years, NT 201, a new botulinum toxin type A (BTX-A) free of complexing proteins, has been used for treating several movement disorders, showing safety and efficacy in upper limb spasticity. AIM: To assess the safety and evaluate the effects of BTX-A NT 201 free from complexing proteins for the treatment of post-stroke lower limb spasticity evaluating spasticity grade, passive ankle dorsi-flexion motion, and muscle's spasms, as well as its efficacy and rate of satisfaction for patients and for the physicians. DESIGN: Prospective open-label study. POPULATION: Patients (71) with post-stroke lower limb spasticity at least 5 months by the event. METHODS: Intramuscular injections of BTX-A NT 201 in soleus, medial, and lateral gastrocnemius with a maximum total dose of 180 U. Each patients was assessed at baseline, 30, and 90 days after treatment using Modified Ashworth Scale, Spasm Frequency Scale, evaluating passive ankle dorsi-flexion motion, and the rate of satisfaction for patients and investigators. RESULTS: Patients treated with BTX-A NT 201 reported a statistically significant reduction in muscle tone and spasms daily increasing passive ankle dorsi-flexion at 30 days, persisting also at 90 days of follow-up. CONCLUSION: BTX-A NT 201 for the treatment of post-stroke lower limb spasticity was safe and efficacious reducing muscle tone and spasms, and improving passive ankle dorsi-flexion movement. CLINICAL REHABILITATION IMPACT: These results confirmed the safety and effectiveness of a new type of BTX-A, with low immunogenity, useful to improve rehabilitative treatment of post-stroke lower limb spasticity. SN - 1973-9095 UR - https://www.unboundmedicine.com/medline/citation/23480980/Safety_and_efficacy_of_incobotulinum_toxin_type_A__NT_201_Xeomin__for_the_treatment_of_post_stroke_lower_limb_spasticity:_a_prospective_open_label_study_ L2 - http://www.minervamedica.it/index2.t?show=R33Y2013N04A0483 DB - PRIME DP - Unbound Medicine ER -