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

NCT02546999 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2022-01-11

No results posted yet for this study

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.

Conditions

  • Cerebral Palsy
  • Muscle Spasticity

Interventions

DRUG

botox

The agent will be given only once at point zero in the time scheme for the project.

DRUG

placebo

The agent will be given only once at point zero in the time scheme for the project.

Sponsors & Collaborators

  • Norwegian University of Science and Technology

    collaborator OTHER

  • The Hospital of Vestfold

    collaborator OTHER

  • University Hospital of North Norway

    collaborator OTHER

  • Oslo University Hospital

    collaborator OTHER

  • Haukeland University Hospital

    collaborator OTHER

  • Fondation Lenval

    collaborator OTHER

  • Mazowieckie Centrum Neuropsychiatrii, Warszawa

    collaborator UNKNOWN

  • St. Olavs Hospital

    lead OTHER

Principal Investigators

  • Petter Aadahl, md prof · St. Olavs Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2021-10-15
Completion
2021-10-15

Countries

  • France
  • Norway
  • Poland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02546999 on ClinicalTrials.gov