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

Cerebral Palsy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00455637
• Other study ID #: Y-97-52120-727
• Secondary ID: 2005-001794-10
• Status: Terminated
• Phase: Phase 2
• Start date: March 2007
• Est. completion date: March 17, 2008

Study information

• Verified date: August 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: March 17, 2008
• Est. primary completion date: March 17, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Biological:
• Botulinum toxin type A

Locations

Country	Name	City	State
United Kingdom	Chailey Heritage Clinical Services	Chailey

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	The primary endpoint will be the change in score in the Paediatric Pain Profile.		From baseline to the week 4 assessment
Secondary	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
Secondary	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
Secondary	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