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Treatment of Drug Resistant Epilepsy

NCT02461706 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2019-01-22

No results posted yet for this study

Summary

The main goal of this study is to provide treatment with cannabidiol (CBD) to children with drug resistant epilepsy through a Physician Expanded Access Investigation New Drug protocol. As the controlled therapeutic use of CBD in children is novel, the primary objective of this study is to evaluate the safety and efficacy of CBD when administered as adjunctive therapy in children that have exhausted the majority of FDA approved antiepileptic drug treatment options.

Conditions

Interventions

DRUG

cannabidiol

All subjects will have a dosing titration starting with 25 mg/kg/day and will be titrated weekly as tolerated based on clinical response. All subjects will be clinically evaluated at baseline, once a month for three months and every three months thereafter. In order to ensure safe use at higher doses, patients receiving more than 600 mg of daily CBD will be evaluated at least monthly until they achieve steady state at the final fixed maintenance dose.

OTHER

Blood Test

All subjects will have the following clinical laboratory tests including changes in bone marrow (CBC), liver (AST, ALT), and kidney function (creatinine, electrolytes, BUN) will be assessed at baseline, each month during months 1 to 3, and every 3 months thereafter.

Sponsors & Collaborators

  • James and Esther King Biomedical Research Program

    collaborator OTHER

  • University of Florida

    lead OTHER

Principal Investigators

  • Steven Winesett, MD · University of Florida

Eligibility

Min Age
2 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02461706 on ClinicalTrials.gov