Status:
TERMINATED
Which is the Best Dose of Dysport in Helping With Hip Pain for Children With Cerebral Palsy?
Lead Sponsor:
Ipsen
Conditions:
Cerebral Palsy
Eligibility:
All Genders
4-16 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 17 2008
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00455637
Start Date
March 1 2007
End Date
March 17 2008
Last Update
August 2 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Chailey Heritage Clinical Services
Chailey, United Kingdom, BN8 4JN