Which is the Best Dose of Dysport in Helping With Hip Pain for Children With Cerebral Palsy?
TerminatedPhase 2NCT00455637
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- 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
- Conditions
- Interventions
- Sponsor
- Ipsen
- Start date
- 2007-03
- Primary completion
- 2008-03-17
- Sex
- All
- Age range
- from 4 Years to 16 Years
- Results posted
- No results posted in this snapshot
- Countries
- United Kingdom
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00455637