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

Condition(s) targeted: Cerebral Palsy

Intervention: Botulinum type A toxin (Dysport®) (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Ipsen

Official(s) and/or principal investigator(s):
Robin Kingswell, MD, Study Director, Affiliation: Ipsen

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.

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 design: Treatment, Randomized, Double-Blind, Dose Comparison, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

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:

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.

Minimum age: 4 Years. Maximum age: 16 Years. Gender(s): Both.

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.

Chailey Heritage Clinical Services, Chailey BN8 4JN, United Kingdom

Starting date: March 2007
Last updated: June 18, 2008