CompletedPhase 1/2

Cannabidiol Expanded Access Study in Medically Refractory Sturge-Weber Syndrome

United States5 participantsStarted 2014-12

Plain-language summary

The purpose of this study is to determine the tolerability and optimal dose of cannabidiol (CBD) as an simultaneous treatment in children and young adults with Sturge-Weber syndrome (SWS) and drug resistant epilepsy.

Who can participate

Age range1 Month – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. liver disease such as cirrhosis, decompensated liver disease, and chronic hepatitis \[i.e. quantifiable hepatitis B virus (HBV)-DNA and/or positive HbsAg, quantifiable hepatitis C virus (HCV)-RNA\]
✕. Uncontrolled diabetes as defined by fasting serum glucose \> 1.5
✕. Active (acute or chronic) or uncontrolled severe infections.
✕. Patients with an active, bleeding diathesis.

What they're measuring

Number of Seizures Per Month

Timeframe: Measured within 56 days before baseline and 56 days before week 14

Trial details

NCT IDNCT02332655

SponsorAnne Comi, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-04

Results submitted2021-10-13

View on ClinicalTrials.gov More Sturge-Weber Syndrome trials