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A Phase IV, 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 Spastic...

Mise à jour : Il y a 4 ans
Référence : EUCTR2005-001794-10

A Phase IV, 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

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Extrait

To compare the effectiveness of 3 doses of Dysport (5, 10 or 15 Units/Kg/painful hip) in the management of chronic hip pain due to cerebral palsy in children/young people. The primary endpoint will be the change in score in the Paediatric Pain Profile from Baseline to the Week 4 assessment. A responder will be defined as having a 20 point reduction in the Paediatric Pain Profile score.

Critère d'inclusion

  • Chronic Hip Pain due to Cerebral Palsy

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