CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 5 enrolled
Drug / intervention
Cannabidioldrug
Likely dose
Cannabidiol 2mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02332655
NCT02332655Phase 2Completed
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Cannabidiol Expanded Access Study in Medically Refractory Sturge-Weber Syndrome

Anne Comi, MD·interventional·Posted Jan 7, 2015·Updated Mar 2, 2022

In Brief

A Phase 2 clinical trial evaluating Cannabidiol for Sturge-Weber Syndrome. Completed, enrolled 5 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSturge-Weber Syndrome
CountriesUnited States
CollaboratorsJazz Pharmaceuticals, Faneca 66 Foundation

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 7, 2015
Enrollment StartDec 1, 2014
Primary CompletionApr 1, 2019
Study CompletionApr 1, 2021
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 11.5 years ago

Interventions

Cannabidioldrug

Initiation of treatment will begin with 2mg/kg/day. The dose will be increased by 3 mg/kg/day after seven days and then by 5 mg/kg/day every seven days up to a maximum dose of 25 mg/kg/day given. The dose of concomitant antiepileptic drugs will remain unchanged during the first 12 weeks of CBD treatment (or until 8 weeks after steady state at final dose), unless symptoms of toxicity and/or significant changes in blood levels are observed.