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Cannabidiol Expanded Access Study in Medically Refractory Sturge-Weber Syndrome

NCT02332655 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2022-03-02

Study results available
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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.

Conditions

  • Sturge-Weber Syndrome

Interventions

DRUG

Cannabidiol

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.

Sponsors & Collaborators

  • Jazz Pharmaceuticals

    collaborator INDUSTRY

  • Faneca 66 Foundation

    collaborator OTHER

  • Anne Comi, MD

    lead OTHER

Principal Investigators

  • Anne M Comi, MD · Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Month
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2019-04-30
Completion
2021-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02332655 on ClinicalTrials.gov