Epidiolex Trial for Presymptomatic Treatment of Sturge-Weber Syndrome

Conditions

• Sturge - Weber Syndrome (SWS)

Eligibility Criteria

Sex

ALL

Age

1 Month - 18 Months

Healthy Volunteers

Not accepted

Interventions

• Epidiolex 100 mg/mL Oral Solution — DRUG
  Epidiolex is a prescription form of cannabidiol used to treat seizures. Epidiolex will be started at 2.5 mg/kg/day divided twice daily. The dose will increase weekly as tolerated over the next 5 weeks to a target dose of 20 mg/kg/day.

Study Details

Patients with Sturge-Weber syndrome (SWS) are frequently affected by seizures, and seizures are associated with poorer neurological outcomes. To date there is no established means of predicting or preventing seizure onset. Cannabidiol (Epidiolex) was well tolerated in an open label study in this population. This trial will evaluate whether Epidiolex in presymptomatic Sturge-Weber patients may delay the onset of seizures and improve neurological outcome.

Key Dates

First listed

Aug 21, 2026

Start date

Aug 31, 2026

Status verified

Aug 2026

Primary completion

Jul 31, 2028

Completion

Jul 31, 2028

Study Design

Enrollment

10 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Presymptomatic Epidiolex Treatment
  Epidiolex will be started at 2.5 mg/kg/day divided twice daily. The dose will increase weekly as tolerated over the next 5 weeks to a target dose of 20 mg/kg/day.

Primary Outcome Measure

Safe completion as assessed by the number of participants with no significant side effects [ Time Frame: 6 months ]

Central Contacts

• Anne Comi, MD
  443-923-9172
  [email protected]
• Brenna Keam, BS
  443-923-9127
  [email protected]

Locations (1)

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