- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02546999
Does Botulinum Toxin A Make Walking Easier in Children With Cerebral Palsy? (WE)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Nice, France
- Lenval Foundation Children's Hospital
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Bergen, Norway, 5000
- Haukeland University Hospital
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Oslo, Norway
- Oslo University Hospital
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Tromsø, Norway
- University Hospital of North-Norway
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Trondheim, Norway
- Department of Orthopaedic Surgery, St. Olavs University Hospital
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Tønsberg, Norway
- Vestfold Hospital trust
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Warsaw, Poland
- Mazowieckie Centrum Neuropsychiatrii, Zagorze
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: botox
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.
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The agent will be given only once at point zero in the time scheme for the project.
Other Names:
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Placebo Comparator: placebo
Sterile 0,9% Sodium Chloride injection The placebo dose will be the same dose in ml as the reconstituted Botox
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The agent will be given only once at point zero in the time scheme for the project.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Energy cost during walking
Time Frame: 6 months
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Will be measured by a 5 minutes walk test (overground walking at comfortable speed) with simultaneous gas exchange.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Activity
Time Frame: 6 months
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Daily activity, measured by a body worn accelerometer over 4 periods of 7 consecutive days.
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6 months
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Perceived improved performance and satisfaction
Time Frame: 6 months
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Assessed by The Canadian Occupational Performance Measure
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6 months
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Recurrent musculoskeletal pain
Time Frame: 6 months
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Assessed by the Child Health Questionnaire (Norwegian version), and elements from the Brief Pain Inventory (Norwegian version)
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6 months
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Walking capacity
Time Frame: 6 months
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Assessed with OMNI-RPE (OMNI Rating of Perceived Exertion) and a 1 Minute walk test at maximal gait speed
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6 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Gait pattern
Time Frame: 6 months
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3D gait analysis will be carried out on a subset of participants.
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6 months
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Ankle strength
Time Frame: 6 months
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Isometric strength of ankle plantar- and dorsiflexors, will be made on a subset of the participants.
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6 months
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Spasticity
Time Frame: 6 months
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Will be assessed by the use of Tardieu scale.
On a subset of participants, concurrent velocity, position and muscle activation will be measured.
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6 months
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Self-perceived effect on walking
Time Frame: 4 weeks
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A qualitative interview will be conducted on a subset of the participants at baseline and post 1 (4 weeks post injection)
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4 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Petter Aadahl, md prof, St. Olavs Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Brain Damage, Chronic
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Manifestations
- Muscle Hypertonia
- Cerebral Palsy
- Muscle Spasticity
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- Botulinum Toxins
- Botulinum Toxins, Type A
Other Study ID Numbers
- 2013/1195
- 2014-002539-32 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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