Which is the Best Dose of Dysport in Helping With Hip Pain for Children With Cerebral Palsy?
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|ClinicalTrials.gov Identifier: NCT00455637|
Recruitment Status : Terminated (Low levels of recruitment)
First Posted : April 4, 2007
Last Update Posted : June 19, 2008
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy||Drug: Botulinum type A toxin (Dysport®)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|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|
|Study Start Date :||March 2007|
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00455637
|Chailey Heritage Clinical Services|
|Chailey, United Kingdom, BN8 4JN|
|Study Director:||Robin Kingswell, MD||Ipsen|