drugset / Trial / NCT02470325

The Effects of Cannabis on Dystonia and Spasticity on Pediatric Patients

NCT02470325 ↗

Phase 2 Unknown 40 enrolled Wolfson Medical Center
RandomizedParallel-groupTriple-blindTreatment

Summary

A clinical trial is planned to study the effects of cannabis on dystonia and spasticity in children with neurological diseases. The clinical trial will include 40 children divided into two groups: children with spasticity and dystonia due to cerebral palsy, and children with spasticity and dystonia due to genetic neurodegenerative diseases. Each group will be randomly divided into two arms and will receive Avidekel cannabis oil 6-to-1 ratio of CBD to THC or enriched Avidekel cannabis oil 20-to-1 ratio of CBD to THC. During the study, various variables will be collected including: medication intake, spasticity, dystonia score, pain scale, restlessness scale, quality of life measures, safety tests, side effects, and an addiction test. The investigators hypothesize that cannabis consumption will reduce dystonia and spasticity in children with motor disability related to genetic neurodegenerative diseases and cerebral palsy and as a result improve motor function, non-motor functions and quality of life.

Timeline

Start
2015-07
Primary completion
2016-12
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Avidekel oil Unknown — —
Comparator Enriched Avidekel oil Unknown — —

Indications