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

August 1, 2019 updated by: Ipsen

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dysport 5 units
Biological: Botulinum toxin type A
Other Names:
  • AbobotulinumtoxinA (Dysport®)
Experimental: Dysport 10 units
Biological: Botulinum toxin type A
Other Names:
  • AbobotulinumtoxinA (Dysport®)
Experimental: Dysport 15 units
Biological: Botulinum toxin type A
Other Names:
  • AbobotulinumtoxinA (Dysport®)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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.
Time Frame: Weeks 12, 16 and 20
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.
Time Frame: Weeks 4, 12, 16 and 20
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.
Time Frame: Weeks 4, 12, 16 and 20
Weeks 4, 12, 16 and 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

March 17, 2008

Study Completion (Actual)

March 17, 2008

Study Registration Dates

First Submitted

April 3, 2007

First Submitted That Met QC Criteria

April 3, 2007

First Posted (Estimate)

April 4, 2007

Study Record Updates

Last Update Posted (Actual)

August 2, 2019

Last Update Submitted That Met QC Criteria

August 1, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Y-97-52120-727
  • 2005-001794-10 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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