Study of Cannabidiol for Drug-Resistant Epilepsies

March 30, 2017 updated by: Eric Marsh, MD

A Phase 1/2, Safety, Tolerability, and Dose-Finding Study of Cannabidiol for Drug-Resistant Epilepsies

The purpose of this study is to determine if cannabidiol is safe and effective at different doses as an additional treatment for pediatric drug-resistant epilepsy. Pure cannabidiol has potentially therapeutic properties, such as anti-convulsant effects, that may reduce seizure frequency. There are only a few open label studies that have demonstrated the safety and tolerance of cannabiodiol in both adult and pediatric epileptic populations--these studies were performed either retrospectively or with varying cannabidiol preparations. There are no well-documented studies and completely analyzed data for pediatric epileptic patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
No longer available

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Expanded Access

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 20 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Ages between 1 year old and 20 years old, male or female at the first visit, Week -4 (at time informed consent form is signed)

  2. Documentation of a diagnosis of drug-resistant epilepsy as proven by and documented with medical records and/or the following clinical features (must have all 3 of the following):

    1. Failure to control seizures despite appropriate trial of 3 or more AEDs at therapeutic doses
    2. An intractable childhood epilepsy including, Dravet Syndrome or Lennox-Gastaut Syndrome
    3. Must report at least 3 countable (non-countable seizures includes absence and myoclonic) seizures per month
  3. Between 1-3 baseline AEDs . Vagus nerve stimulator (VNS), ketogenic diet, and modified Atkins diet do not count towards this limit.
  4. VNS must be on stable settings for a minimum of 3 months.
  5. If on the ketogenic diet, must be on stable ratio for a minimum of 3 months.

Exclusion Criteria:

  1. Epilepsies associated with neurodegenerative diseases, including neuronal ceroidolipofuscinosis, progressive myoclonus epilepsies, Rasmussen encephalitis, and tumors
  2. Epilepsies associated with an inborn error of metabolism, including mitochondrial disorders
  3. Felbatol initiated within the past 12 months
  4. Use of any Cannabis-related product (including hemp oil) in the past 12 months as assessed by parental questioning.
  5. Laboratory values on comprehensive metabolic panel (CMP) and complete blood count (CBC) testing that are Class 3 or higher according to the CTCAE v4.0.
  6. Positive pregnancy test.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eric Marsh, MD

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Pittsburgh
Geisinger Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 13-010562

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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