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

Sponsored by:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00455637

Purpose

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.

Condition	Intervention	Phase
Cerebral Palsy	Drug: Botulinum type A toxin (Dysport®)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Botox Cerebral Palsy Paralysis

U.S. FDA Resources

Further study details as provided by Ipsen:

Primary Outcome Measures:

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.
The primary endpoint will be the change in score in the Paediatric Pain Profile. [ Time Frame: From baseline to the week 4 assessment ]

Secondary Outcome Measures:

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 ]
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 ]
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 ]

Estimated Enrollment:	40
Study Start Date:	March 2007

Eligibility

Ages Eligible for Study:	4 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00455637

Locations

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

Sponsors and Collaborators

Ipsen

Investigators

Study Director:

Robin Kingswell, MD

Ipsen

More Information

No publications provided

Responsible Party:	Ipsen ( Robin Kingswell )
Study ID Numbers:	Y-97-52120-727
Study First Received:	April 3, 2007
Last Updated:	June 18, 2008
ClinicalTrials.gov Identifier:	NCT00455637 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Paralysis
Muscle Spasticity
Botulinum Toxins
Cerebral Palsy
Brain Damage, Chronic
Central Nervous System Diseases

Pain
Peripheral Nervous System Agents
Botulinum Toxin Type A
Brain Diseases
Brain Injuries

Additional relevant MeSH terms:

Cerebral Palsy
Physiological Effects of Drugs
Nervous System Diseases
Brain Damage, Chronic
Central Nervous System Diseases

Neuromuscular Agents
Peripheral Nervous System Agents
Botulinum Toxin Type A
Brain Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009