Mobile

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...

Update Il y a 4 ans
Reference: 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

Woman and Man

  • | Country :
    • -
  • | organs :
    • -
  • | Specialty :
    • -

Extract

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.

Inclusion criteria

  • Chronic Hip Pain due to Cerebral Palsy

Links