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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00455637

Enrollment

Registered

2007-04-04

Start date

2007-03-31

Completion date

2008-03-17

Last updated

2019-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

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.

Interventions

BIOLOGICALBotulinum toxin type A

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

4 Years to 16 Years

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.

Design outcomes

Primary

Measure	Time frame
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.	From baseline to the end of study (week 20)
The primary endpoint will be the change in score in the Paediatric Pain Profile.	From baseline to the week 4 assessment

Secondary

Measure	Time frame
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.	Weeks 12, 16 and 20
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.	Weeks 4, 12, 16 and 20
To compare the effect of the different doses of Dysport on oral analgesia intake for hip pain at all assessment time points.	Weeks 4, 12, 16 and 20

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026