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Cannabidiol in Children and Young Adults With Rare Disease-associated Severe Epilepsy

Study acronym: CBD_RE
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
This is a pilot, open-label, phase II study. The main objective of the study is to demonstrate that Cannabidiol (CBD), used in addition to current anti-seizure medications (ASMs) reduces the number and/or severity of motor (generalized, focal, or both) seizures in children and young adults with rare disease-associated severe epilepsy. Secondary objectives include assessment of safety and tolerability, changes in behaviour, cognition and sleep, pharmacokinetic interaction with concurrent ASMs.
Trial Details
NCT Number NCT05803434
Lead Sponsor Meyer Children's Hospital IRCCS
Conditions
(from sponsor)
Epilepsy, Rare Diseases
Related terms Drug Resistant Epilepsy, Epilepsy, Rare Diseases
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov