Does Botulinum Toxin A Make Walking Easier in Children With Cerebral Palsy?
Summary
In Norway, about 60% of all children with cerebral palsy (CP) are being treated with botulinum toxin A (BoNT-A) at 6 years of age, mainly in the legs. Despite this widespread use of the drug, the evidence for a positive effect on walking is insufficient. Moreover, large variation in effect is seen by clinicians. The main objective of the present study is to investigate whether injections with BoNT-A in the calf muscles make walking easier in children with spastic CP within 6 months, reflected by reduced energy cost during walking.
Timeline
- Start
- 2015-09
- Primary completion
- 2021-10-15
- Completion
- 2021-10-15
Outcome
Missed primary endpoint
paper The mean change in energy cost did not differ significantly between groups at the primary time point P2 PMID 39058740 ↗
paper One treatment with BoNT-A was not superior to placebo in making walking easier in children with CP PMID 39058740 ↗
Publications
- Background Braendvik SM, Roeleveld K, Andersen GL, Raftemo AE, Ramstad K, Majkic-Tajsic J, Lamvik T, Lund B, Follestad T, Vik T. The WE-Study: does botulinum toxin A make walking easier in children with cerebral palsy?: Study protocol for a randomized controlled trial. Trials. 2017 Feb 6;18(1):58. doi: 10.1186/s13063-016-1772-8.
- Braendvik SM, Ross Raftemo AE, Roeleveld K, Andersen GL, Ramstad K, Follestad T, Aarli A, Bonikowski M, Vik T; Walking Easier. Does botulinum neurotoxin A make walking easier in children with cerebral palsy? A randomized clinical trial. Dev Med Child Neurol. 2025 Feb;67(2):263-271. doi: 10.1111/dmcn.16038. Epub 2024 Jul 26.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | botulinum neurotoxin A | Unknown | 2 iu/kg | Intramuscular |
| Subject | botulinum neurotoxin A | Unknown | 50 iu | Intramuscular |
| Subject | botulinum neurotoxin A | Unknown | 60 iu | Intramuscular |
| Subject | botulinum neurotoxin A | Unknown | 420 iu | Intramuscular |