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Treatment of Drug Resistant Epilepsy (Cannabidiol)

Primary Purpose

Epilepsy

Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
cannabidiol
Blood Test
Sponsored by
University of Florida
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Epilepsy focused on measuring Drug resistant epilepsy

Eligibility Criteria

2 Years - 16 Years (Child)All Sexes

Inclusion Criteria:

  • history of a trial of at least four drugs, including one trial of a combination of two concomitant drugs, without successful seizure control.
  • Vagal nerve stimulation: VNS must be on stable settings for a minimum of 1 month,
  • RNS deep brain stimulation, or
  • the ketogenic diet can be considered equivalent to a drug trial and must be on a stable ratio for a minimum of 3 months.
  • anti-epileptic drugs at stable doses for a minimum of 4 weeks prior to enrollment.
  • 4 clinically countable seizures per month: Seizure history to include a documented history of generalized seizures (drop attacks, atonic, tonic-clonic and/or myoclonic), focal seizures without loss of consciousness with a motor component, focal seizures with loss of consciousness, or focal seizures with secondary generalization,

Exclusion Criteria:

  • Use of CBD based product within the previous 30 days.
  • Initiation of felbamate within 6 months.
  • Allergy to CBD or any cannabinoid.
  • Unable to comply with study visits/requirements.
  • Diagnosis of Dravet Syndrome or Lennox-Gastaut syndrome will be excluded completely from this trial.
  • Cannabidiol is contraindicated in pregnancy. Female subjects who are pregnant will be excluded from the study. If a female subject is able to become pregnant, she will be given a serum pregnancy test before entry into the study. Female subjects will be informed not become pregnant while taking cannabidiol. Female subjects must tell the investigator and consult an obstetrician or maternal-fetal specialist if they become pregnant during the study.

Sites / Locations

  • University of Flordia CRC
  • Nicklaus Children's Hospital, Miami Children's Health System

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 1, 2015
Last Updated
January 18, 2019
Sponsor
University of Florida
Collaborators
James and Esther King Biomedical Research Program
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1. Study Identification

Unique Protocol Identification Number
NCT02461706
Brief Title
Treatment of Drug Resistant Epilepsy
Acronym
Cannabidiol
Official Title
Physician Expanded Access to Investigational New Drug Cannabidiol for the Treatment of Drug Resistant Epilepsy
Study Type
Expanded Access

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
James and Esther King Biomedical Research Program

4. Oversight

5. Study Description

Brief 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.
Detailed Description
Fifty, (50) children will be provided CBD as part of the Principal Investigator's Physician Expanded Access IND. CBD will be administered as an adjunct to all current antiepileptic drugs. After the screening visit, a 4 week baseline period will be followed and seizures will be recorded in the seizure diary given to the patient at this time. The patients will be clinically evaluated at baseline, once a month for three months and once every three months thereafter. For the first week after study initiation, patients will be called at day 3 to review any changes in condition and again at day 7 to review any changes in condition and to determine whether an increase in dosing is required. Subsequently, patients will be called each week during the titration period to review any changes in condition and determine whether an increase in dosing is required. Maximal dose titration should be achieved in most patients within 5 weeks. In order to ensure safe use at higher doses, patients who receive more than 600 mg of daily CBD will be evaluated at least monthly until they achieve steady state at their final fixed maintenance dose. The investigator will be available by telephone or email throughout the initial four months of the study in between the visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Drug resistant epilepsy

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cannabidiol
Other Intervention Name(s)
CBD
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Blood Test
Intervention Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Eligibility Criteria
Inclusion Criteria: history of a trial of at least four drugs, including one trial of a combination of two concomitant drugs, without successful seizure control. Vagal nerve stimulation: VNS must be on stable settings for a minimum of 1 month, RNS deep brain stimulation, or the ketogenic diet can be considered equivalent to a drug trial and must be on a stable ratio for a minimum of 3 months. anti-epileptic drugs at stable doses for a minimum of 4 weeks prior to enrollment. 4 clinically countable seizures per month: Seizure history to include a documented history of generalized seizures (drop attacks, atonic, tonic-clonic and/or myoclonic), focal seizures without loss of consciousness with a motor component, focal seizures with loss of consciousness, or focal seizures with secondary generalization, Exclusion Criteria: Use of CBD based product within the previous 30 days. Initiation of felbamate within 6 months. Allergy to CBD or any cannabinoid. Unable to comply with study visits/requirements. Diagnosis of Dravet Syndrome or Lennox-Gastaut syndrome will be excluded completely from this trial. Cannabidiol is contraindicated in pregnancy. Female subjects who are pregnant will be excluded from the study. If a female subject is able to become pregnant, she will be given a serum pregnancy test before entry into the study. Female subjects will be informed not become pregnant while taking cannabidiol. Female subjects must tell the investigator and consult an obstetrician or maternal-fetal specialist if they become pregnant during the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Winesett, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Flordia CRC
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Nicklaus Children's Hospital, Miami Children's Health System
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Treatment of Drug Resistant Epilepsy

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