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Study of Cannabidiol for Drug-Resistant Epilepsies

Primary Purpose

Drug Resistant Epilepsy

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Cannabidiol
Sponsored by
Eric Marsh, MD
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Drug Resistant Epilepsy

Eligibility Criteria

1 Year - 20 Years (Child, Adult)All Sexes

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    January 5, 2017
    Last Updated
    March 30, 2017
    Sponsor
    Eric Marsh, MD
    Collaborators
    University of Pittsburgh, Geisinger Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03014440
    Brief Title
    Study of Cannabidiol for Drug-Resistant Epilepsies
    Official Title
    A Phase 1/2, Safety, Tolerability, and Dose-Finding Study of Cannabidiol for Drug-Resistant Epilepsies
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    No longer available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Eric Marsh, MD
    Collaborators
    University of Pittsburgh, Geisinger Clinic

    4. Oversight

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Drug Resistant Epilepsy

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Cannabidiol
    Other Intervention Name(s)
    CBD, Epidiolex

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    20 Years
    Eligibility Criteria
    Inclusion Criteria: 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) 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): Failure to control seizures despite appropriate trial of 3 or more AEDs at therapeutic doses An intractable childhood epilepsy including, Dravet Syndrome or Lennox-Gastaut Syndrome Must report at least 3 countable (non-countable seizures includes absence and myoclonic) seizures per month Between 1-3 baseline AEDs . Vagus nerve stimulator (VNS), ketogenic diet, and modified Atkins diet do not count towards this limit. VNS must be on stable settings for a minimum of 3 months. If on the ketogenic diet, must be on stable ratio for a minimum of 3 months. Exclusion Criteria: Epilepsies associated with neurodegenerative diseases, including neuronal ceroidolipofuscinosis, progressive myoclonus epilepsies, Rasmussen encephalitis, and tumors Epilepsies associated with an inborn error of metabolism, including mitochondrial disorders Felbatol initiated within the past 12 months Use of any Cannabis-related product (including hemp oil) in the past 12 months as assessed by parental questioning. 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. Positive pregnancy test.

    12. IPD Sharing Statement

    Learn more about this trial

    Study of Cannabidiol for Drug-Resistant Epilepsies

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