Epidiolex Trial for Presymptomatic Treatment of Sturge-Weber Syndrome

Study acronym: Epi-Pre
StatusRecruiting
PhasePhase 2
Started

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Record History

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  1. Start date changed from estimate of Sep 2026 to Sep 17, 2026
  2. Recruitment opened
    • Site details revised
  3. Start date: Aug 2026 to Sep 2026
    • Interventions: Epidiolex 100 mg/mL Oral Solution (Drug) to Epidiolex 100 mg/mL Oral Solution (Drug)
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 5 of 5 entries
  4. Secondary endpoints: details revised at 1 of 5 entriesv2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Johns Hopkins University
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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.
Trial Details
NCT Number NCT07778810
Lead Sponsor Johns Hopkins University
Collaborators: Jazz Pharmaceuticals, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Conditions
(from sponsor)		 Sturge - Weber Syndrome (SWS)
Related terms Brain Stem Infarctions
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov