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Toxins (Basel). 2017 Aug 18;9(8). pii: E252. doi: 10.3390/toxins9080252.

Efficacy and Safety of Letibotulinum Toxin A for the Treatment of Dynamic Equinus Foot Deformity in Children with Cerebral Palsy: A Randomized Controlled Trial.

Author information

1
Department of Physical Medicine and Rehabilitation, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon 51353, South Korea. reh.chj@gmail.com.
2
Department of Rehabilitation Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon 16247, South Korea. byhong@catholic.ac.kr.
3
Department of Rehabilitation Medicine, Daejeon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Daejeon 34943, South Korea. upperlimb@catholic.ac.kr.
4
Department of Rehabilitation Medicine, Keimyung University, Dongsan Medical Center, Daegu 41931, South Korea. sylee@dsmc.or.kr.
5
Department of Rehabilitation Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul 06591, South Korea. drpjh@catholic.ac.kr.
6
Department of Physical and Rehabilitation Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, South Korea. jeongyi@gmail.com.

Abstract

The objective of this clinical trial was to compare the efficacy and safety of letibotulinum toxin A and onabotulinum toxin A for improving dynamic equinus foot deformity in children with cerebral palsy (CP). In total, 144 children with spastic CP who had dynamic equinus foot deformity were assigned randomly to the Botulax group (injection of letibotulinum toxin A) or the Botox group (injection of onabotulinum toxin A). The Physician's Rating Scale (PRS), ankle plantar flexor spasticity using the Modified Tardieu Scale, the Gross Motor Function Measure (GMFM)-88, and the GMFM-66 were completed before injection and at 6, 12, and 24 weeks after injection. The PRS responder rate was 60.27% in the Botulax group and 61.43% in the Botox group at 12 weeks after treatment, and the lower limit of the 95% confidence interval for the between-group difference in responder rates was -17.16%, higher than the non-inferiority margin of -24.00%. The clinical efficacy and the safety profiles of the groups did not significantly differ. The results suggest that injection of letibotulinum toxin A is as effective and safe as that of onabotulinum toxin A for the treatment of dynamic equinus foot deformity in children with spastic CP.

KEYWORDS:

botulinum toxin; cerebral palsy; letibotulinum toxin; onabotulinum toxin; spasticity

PMID:
28820439
PMCID:
PMC5577586
DOI:
10.3390/toxins9080252
[Indexed for MEDLINE]
Free PMC Article

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