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

Ipsen

Status and phase

Terminated

Phase 2

Conditions

Cerebral Palsy

Treatments

Biological: Botulinum toxin type A

Study type

Interventional

Funder types

Industry

Identifiers

NCT00455637

Y-97-52120-727

2005-001794-10 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

4 to 16 years old

Volunteers

No Healthy Volunteers

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.