Which is the Best Dose of Dysport in Helping With Hip Pain for Children With Cerebral Palsy?

Study Overview
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Brief Summary
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The purpose of the study is to compare the effectiveness of 3 doses of Dysport (5, 10 or 15 Units/Kg/hip) in the management of chronic bilateral hip pain due to cerebral palsy in children/young people.

Official Title
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A Phase II, Randomised, Double-blind, Dose-ranging Study in Children and Young People to Determine the Optimal Dose of Botulinum Toxin Type-A (Dysport®) in Managing the Symptoms of Hip Muscle Spasticity Due to Cerebral Palsy

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Biological: Botulinum toxin type A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged between 4 and 16 years (inclusive). Diagnosis of cerebral palsy. Presence of clinical bilateral hip pain (of at least 6 months duration) due to cerebral palsy as defined by the child/young person and/or parents. Paediatric Pain Profile score of 25 or greater. Exclusion Criteria: Prior treatment with Botulinum toxin (any serotype, administered anywhere in the body) within 4 months prior to Screening. Planned or anticipated requirement for surgery during the study period. History of hypersensitivity to the investigational drug or any of its excipients. Likely to require treatment during the study with drugs that are not permitted by the study protocol or that in the opinion of the Investigator may interfere with the evaluation of the efficacy or safety of the study medication.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dysport 5 units<br> | Biological: Botulinum toxin type A<br> <br> * Other names: AbobotulinumtoxinA (Dysport®);|
| Experimental: Dysport 10 units<br> | Biological: Botulinum toxin type A<br> <br> * Other names: AbobotulinumtoxinA (Dysport®);|
| Experimental: Dysport 15 units<br> | Biological: Botulinum toxin type A<br> <br> * Other names: AbobotulinumtoxinA (Dysport®);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the effectiveness of 3 doses of Dysport (5, 10 or 15 Units/Kg/hip) in the management of chronic bilateral hip pain due to cerebral palsy in children/young people. |  | From baseline to the end of study (week 20) | 
| The primary endpoint will be the change in score in the Paediatric Pain Profile. |  | From baseline to the week 4 assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the effectiveness of 3 doses of Dysport (5, 10 or 15 Units/Kg/hip) in the management of hip pain as assessed by the change in the score of the Paediatric Pain Profile at all other assessment time points. |  | Weeks 12, 16 and 20 | 
| To compare the effect of the different doses of Dysport on sleep pattern and quality as assessed using a sleep diary and sleep questionnaire at all assessment time points. |  | Weeks 4, 12, 16 and 20 | 
| To compare the effect of the different doses of Dysport on oral analgesia intake for hip pain at all assessment time points. |  | Weeks 4, 12, 16 and 20 |