NCT04447846

Novel Cognitive Treatment Targets for Epidiolex in Sturge- Weber Syndrome

Novel Cognitive Treatment Targets for Epidiolex in Sturge- Weber Syndrome: A Phase II Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Anne Comi, MD · Academic / Other
• Sex: All
• Age: 3 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to better understand the utility of cannabidiol (CBD/ Epidiolex) for improving the treatment of cognitive impairments in Sturge-Weber syndrome (SWS).

Detailed description

The investigators hope to gain an understanding of the utility of pharmaceutical grade CBD used for the treatment of cognitive impairments in SWS in this open-label study. Anecdotal evidence from a phase I trial investigating the use of CBD for medically refractory seizures suggests CBD may also have a beneficial effect on cognition, mood, and behavior. The investigators hypothesize that CBD/ Epidiolex will improve SWS brain function resulting in improved cognitive function, social interactions, mood, motor function and behavior, as well as reduced migraines. This is an open-label prospective oral drug trial of Epidiolex in 10 subjects. Assessments will be done at baseline and repeated after 6 months on study drug.

Conditions

• Sturge-Weber Syndrome

Interventions

Type	Name	Description
DRUG	Cannabidiol	Initiation of treatment will begin with 5 mg/kg/day given in two divided doses. The dose will be increased by 5 mg/kg/day after seven days and then by 5 mg/kg/day every seven days up to a maximum dose of 20 mg/kg/day given.

Timeline

• Start date: 2019-10-14
• Primary completion: 2021-08-16
• Completion: 2022-12-09
• First posted: 2020-06-25
• Last updated: 2023-05-25
• Results posted: 2023-05-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study