Back to resultsWhich is the Best Dose of Dysport in Helping With Hip Pain for Children With Cerebral Palsy?
Primary Purpose
Cerebral Palsy
Status
Terminated
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Botulinum toxin type A
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy
Eligibility Criteria
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.
Sites / Locations
- Chailey Heritage Clinical Services
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Dysport 5 units
Dysport 10 units
Dysport 15 units
Arm Description
Outcomes
Primary Outcome Measures
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.
The primary endpoint will be the change in score in the Paediatric Pain Profile.
Secondary Outcome Measures
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.
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.
To compare the effect of the different doses of Dysport on oral analgesia intake for hip pain at all assessment time points.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00455637
Brief Title
Which is the Best Dose of Dysport in Helping With Hip Pain for Children With Cerebral Palsy?
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
Low levels of recruitment
Study Start Date
March 2007 (undefined)
Primary Completion Date
March 17, 2008 (Actual)
Study Completion Date
March 17, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dysport 5 units
Arm Type
Experimental
Arm Title
Dysport 10 units
Arm Type
Experimental
Arm Title
Dysport 15 units
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Botulinum toxin type A
Other Intervention Name(s)
AbobotulinumtoxinA (Dysport®)
Primary Outcome Measure Information:
Title
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.
Time Frame
From baseline to the end of study (week 20)
Title
The primary endpoint will be the change in score in the Paediatric Pain Profile.
Time Frame
From baseline to the week 4 assessment
Secondary Outcome Measure Information:
Title
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.
Time Frame
Weeks 12, 16 and 20
Title
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.
Time Frame
Weeks 4, 12, 16 and 20
Title
To compare the effect of the different doses of Dysport on oral analgesia intake for hip pain at all assessment time points.
Time Frame
Weeks 4, 12, 16 and 20
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Chailey Heritage Clinical Services
City
Chailey
ZIP/Postal Code
BN8 4JN
Country
United Kingdom
12. IPD Sharing Statement
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Which is the Best Dose of Dysport in Helping With Hip Pain for Children With Cerebral Palsy?
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