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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-03-17

Brief Summary

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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.

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Detailed Description

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Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Dysport 5 units

Group Type EXPERIMENTAL

Botulinum toxin type A

Intervention Type BIOLOGICAL

Dysport 10 units

Group Type EXPERIMENTAL

Botulinum toxin type A

Intervention Type BIOLOGICAL

Dysport 15 units

Group Type EXPERIMENTAL

Botulinum toxin type A

Intervention Type BIOLOGICAL

Interventions

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Botulinum toxin type A

Intervention Type BIOLOGICAL

Other Intervention Names

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AbobotulinumtoxinA (Dysport®)

Eligibility Criteria

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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.

Minimum Eligible Age

4 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No