NCT00455637

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 4, 2007

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2008

Completed
Last Updated

August 2, 2019

Status Verified

August 1, 2019

Enrollment Period

1 year

First QC Date

April 3, 2007

Last Update Submit

August 1, 2019

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • 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

Study Arms (3)

Dysport 5 units

EXPERIMENTAL
Biological: Botulinum toxin type A

Dysport 10 units

EXPERIMENTAL
Biological: Botulinum toxin type A

Dysport 15 units

EXPERIMENTAL
Biological: Botulinum toxin type A

Interventions

Botulinum toxin type ABIOLOGICAL
Also known as: AbobotulinumtoxinA (Dysport®)
Dysport 10 unitsDysport 15 unitsDysport 5 units

Eligibility Criteria

Age4 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chailey Heritage Clinical Services

Chailey, BN8 4JN, United Kingdom

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Botulinum Toxins, Type AabobotulinumtoxinA

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Ipsen Medical Director

    Ipsen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2007

First Posted

April 4, 2007

Study Start

March 1, 2007

Primary Completion

March 17, 2008

Study Completion

March 17, 2008

Last Updated

August 2, 2019

Record last verified: 2019-08

Locations

GB(1)