Phase 2Active, not recruiting
Cannabidiol in Children and Young Adults With Rare Disease-associated Severe Epilepsy (CBD_RE)
Open-label Pilot Study to Assess the Efficacy and Safety of Cannabidiol Oral Solution as an Adjunctive Treatment for Children and Young Adults With Rare Disease-associated Severe Epilepsy
- Sponsor
- Meyer Children's Hospital IRCCS (Academic or other)
- Enrollment
- 30 planned
- Conditions
- Epilepsy; Rare Diseases
- Interventions
- Cannabidiol oral solution
- Ages
- children, adults
- Registry
- NCT05803434
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Change in number of generalized and/or focal motor-onset seizure frequency
- Change in severity of generalized and/or focal motor-onset seizure frequency
History
Study completion expected
Last registry update
Primary completion
Started
Registered