A Phase 4 interventional study of botox and placebo in Cerebral Palsy and Muscle Spasticity, sponsored by St. Olavs Hospital. Completed at 7 sites in 3 countries. Open to participants aged 4 Years to 17 Years. Per ClinicalTrials.gov, last updated 2022-01-11.
Sponsored by St. Olavs Hospital · Phase 4, Interventional, and Treatment
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.
This is an industry independent multicentre clinical trial. The randomization will be done by a computer number random generator and will be carried out and held by the unit of Applied Clinical Research at NTNU. Two strata: age and center.
The study will be conducted according to Consort guidelines and guidelines for Good Clinical Practice. It is approved by the local Ethical committee (REK Nord) and the Norwegian Drug Agency.
Primary research question is: Do BoNT-A injections in the calf muscles make walking easier in children with CP? Secondary research questions: 1) Do BoNT-A injections in the calf muscles increase activity? 2) Do BoNT-A injections in the calf muscles improve walking capacity 3) Do BoNT-A injections in the calf muscles improve perceived performance and satisfaction related to mobility tasks and 4) Do BoNT-A injections in the calf muscles reduce recurrent musculoskeletal pain? The participants will receive the treatment with both local anaesthesia and conscious sedation with oral or nasal benzodiazepines.Outcome measures are made at baseline and 4, 12 and 24 weeks after treatment, with primary endpoint at 12 weeks.
Data will be analyzed using a linear mixed model (LMM). The difference in change in the primary outcome measure (energy cost during walking) between the treated and placebo groups will be done using a post hoc test following the LMM. Secondary, the same model will be used to test for an effect also at 4 and 24 weeks post injection. Age, GMFCS Level, number of prior BoNT-A treatments and study center will be considered as potential covariates.
A substudy will be conducted within the frames of this RCT, aiming to identify characteristics of those who respond to the treatment compared to those who do not respond (outcome measures 6, 7,8 and 9).
704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.
This study's enrollment of 61 is above the median of 36 across 525 interventional studies indexed under Muscle Spasticity.
Browse Muscle Spasticity studies →St. Olavs Hospital is the lead sponsor of 165 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Botox® (onabotulinumtoxin A),injections in the calf muscles. The total maximum body dose of Botox® in this study will be 420 Units. Maximum dose per injection site will be 50 Units. The gastrocnemius muscle will receive 5-6 Units Botox® per kg, but maximum 180 Units in each leg. The soleus muscle will receive 2 Units Botox® per kg with maximum dose 60 Units in each leg. Dilution: 100 Units Botox® in 1 ml 0.9% sodium chloride, and the maximum volume per injection site will be 0,5 ml in both study groups. The route of administration is intramuscular injection.
Drug: botox
Sterile 0,9% Sodium Chloride injection The placebo dose will be the same dose in ml as the reconstituted Botox
Drug: placebo
The agent will be given only once at point zero in the time scheme for the project.
Also known as: botulinum toxin A
The agent will be given only once at point zero in the time scheme for the project.
Also known as: sodium chloride
Energy cost during walking
Will be measured by a 5 minutes walk test (overground walking at comfortable speed) with simultaneous gas exchange.
Time frame: 6 months
Activity
Daily activity, measured by a body worn accelerometer over 4 periods of 7 consecutive days.
Time frame: 6 months
Perceived improved performance and satisfaction
Assessed by The Canadian Occupational Performance Measure
Time frame: 6 months
Recurrent musculoskeletal pain
Assessed by the Child Health Questionnaire (Norwegian version), and elements from the Brief Pain Inventory (Norwegian version)
Time frame: 6 months
Walking capacity
Assessed with OMNI-RPE (OMNI Rating of Perceived Exertion) and a 1 Minute walk test at maximal gait speed
Time frame: 6 months
Gait pattern
3D gait analysis will be carried out on a subset of participants.
Time frame: 6 months
Ankle strength
Isometric strength of ankle plantar- and dorsiflexors, will be made on a subset of the participants.
Time frame: 6 months
Spasticity
Will be assessed by the use of Tardieu scale. On a subset of participants, concurrent velocity, position and muscle activation will be measured.
Time frame: 6 months
Self-perceived effect on walking
A qualitative interview will be conducted on a subset of the participants at baseline and post 1 (4 weeks post injection)
Time frame: 4 weeks
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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St. Olavs Hospital