A Safety, Efficacy and Tolerability Study of Sativex for the Treatment of Spasticity in Children … (NCT01898520) | Clinical Trial Compass
CompletedPhase 3
A Safety, Efficacy and Tolerability Study of Sativex for the Treatment of Spasticity in Children Aged 8 to 18 Years
Czechia, Israel, United Kingdom72 participantsStarted 2013-12
Plain-language 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.
Who can participate
Age range8 Years – 18 Years
SexALL
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Inclusion Criteria:
* Males and females aged between 8 and 18 years suffering from cerebral palsy or traumatic central nervous system injury.
* Participant and/or authorised representative willing and able to give informed consent for participation in the study.
* To have been under treatment for their spasticity for at least one year and to have reached a stage of non-progressive spasticity.
* Participant able (in the investigators opinion) and willing to comply with all study requirements.
* Participant has received inadequate efficacy and/or experienced unacceptable side effects from previous or current treatment with at least one of the following medications for spasticity:
Baclofen, Diazepam (or another benzodiazepine), Dantrolene, Tizanidine, Gabapentin, Trihexyphenidyl.
* Gross Motor Function Classification Scale Level III - V.
* MAS of two or higher in at least one muscle group.
* Participant and/or authorised representative willing for his or her name to be notified to the responsible authorities for participation in this study, as applicable in individual countries.
* Participant and/or authorised representative willing to allow his or her primary care practitioner and consultant, if appropriate, to be notified of participation in the study.
Exclusion Criteria:
* Any known or suspected history of:
* Schizophrenia or other psychotic illness, or diagnosis of schizophrenia in a first-degree relative.
* Alcohol or substance abuse.
* Any known or suspected hype…
What they're measuring
1
Change from baseline to the end of 12 weeks' treatment in mean spasticity 0-10 NRS score