Cerebral Palsy Clinical Trial
Official title:
The Efficacy, Safety and Tolerability of Sativex as an Adjunctive Treatment to Existing Anti-spasticity Medications in Children Aged 8 to 18 Years With Spasticity Due to Cerebral Palsy or Traumatic Central Nervous System Injury Who Have Not Responded Adequately to Their Existing Anti-spasticity Medications: a Parallel Group Randomised, Double-blind, Placebo-controlled Study Followed by a 24-week Open Label Extension Phase
A study to assess the effects of Sativex treatment on spasticity in a population of children and adolescents aged from 8 to 18 years with cerebral palsy or traumatic central nervous system injury. Efficacy (ability to improve symptoms), safety and tolerability will be monitored.
A 12 week randomised, double-blind, placebo-controlled,parallel group study followed by a 24-week open-label extension phase. The primary objective is to assess the efficacy of Sativex treatment using a spasticity 0-10 numerical rating scale (NRS). The endpoint for analysis is the comparison between Sativex and placebo in the change from baseline to the end of the acute phase in mean spasticity 0-10 NRS scores (week 12 or last seven days prior to withdrawal). The secondary objectives are to assess the safety and tolerability of Sativex via volunteered adverse events, laboratory parameters and vital signs. The efficacy of Sativex compared to placebo is also investigated for the following outcomes: spasticity (modified tardieu scale (MTS) score of the most affected limb and the modified ashworth scale (MAS) score of the main muscle groups of the upper and lower limb), sleep quality (sleep 0-10 NRS), pain (paediatric pain profile [PPP]), quality of life (of both the participant and the caregiver; cerebral palsy quality of life (QOL) questionnaire and caregiver QOL questionnaire), comfort (comfort questionnaire), depression assessment (childrens depression inventory (CDI 2)) and the caregiver's global impression of change (CGIC). ;
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