drugset / Trial / NCT01898520

A Safety, Efficacy and Tolerability Study of Sativex for the Treatment of Spasticity in Children Aged 8 to 18 Years

NCT01898520

Phase 3 Completed 72 enrolled Jazz Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2013-12
Primary completion
2016-09
Completion
2017-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Nabiximols Other / unclassified 2.5 mg Oral
Comparator Nabiximols Other / unclassified 2.7 mg Oral

Indications