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

• Status: Terminated
• Trial end date: 0000-00-00
• Target enrollment: 40
• Participant gender: Both

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA
• Last Updated: 2008-06-18

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.