Does Botulinum Toxin A Make Walking Easier in Children With Cerebral Palsy?

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Olavs Hospital
• Collaborators: Fondation Lenval; Haukeland University Hospital; Mazowieckie Centrum Neuropsychiatrii, Warszawa; Norwegian University of Science and Technology; Oslo University Hospital; The Hospital of Vestfold; University Hospital of North Norway
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion criteria:

• Diagnosed with unilateral or bilateral CP

• GMFCS level I and II

• Signed informed consent

• expected cooperation of the patients for the treatment and follow up.

Exclusion Criteria:

• BoNT-A injections in the lower legs in the last 6 months before intervention

• history of adverse reactions to BoNT-A

• Known hypersensitivity to BoNT-A or to any of the excipients

• Orthopedic surgery in the legs in the last 2 years

• Major cognitive impairments (must be able to take verbal instructions and conduct the test procedure)

• infection at the proposed injection site(s)

• Subclinical or clinical evidence of defective neuromuscular transmission e.g. myasthenia gravis or Lambert-Eaton Syndrome in patients with peripheral motor neuropathic diseases (e.g. amyotrophic lateral sclerosis or motor neuropathy)

• other underlying neurological disorders that may be affected by BoNT-A injections

• Use of aminoglycoside antibiotics or spectinomycin, or other medicinal products that interfere with neuromuscular transmission (e.g. neuromuscular blocking agents)

• Pregnant or breast-feeding

• Childbearing potential not using contraception

• any reason why, in the opinion of the investigator, the patient should not participate

• Children needing deep sedation under treatment