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Safety and Tolerability of Cannabidiol in Subjects With Drug Resistant Epilepsy (CBD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02660255
Expanded Access Status : Approved for marketing
First Posted : January 21, 2016
Last Update Posted : May 30, 2019
Sponsor:
Collaborator:
GW Pharmaceuticals Ltd.
Information provided by (Responsible Party):
Christopher J. Kratochvil, M.D., University of Nebraska

Brief Summary:
This is an observational, open-label, flexible dose study that will prospectively and longitudinally assess the effect of Cannabidiol (CBD) therapy in patients with drug-resistant epilepsies through a Physician Expanded Access Investigational New Drug protocol.

Condition or disease Intervention/treatment
Epilepsy Drug: Cannabidiol

Detailed Description:

This study will test if Cannabidiol (CBD) therapy is safe in humans and reduces the number and/or severity of seizures in patients with drug resistant epilepsy when taken in addition to current anti-epileptic drugs (AEDs).

To be eligible, subjects must:

  • have drug-resistant epilepsy
  • be between 1 and 60 years of age

Subjects may participate for up to 2 years and may continue to receive the drug as available, until the compassionate use is terminated or the drug becomes approved by the FDA.

The study includes:

  • Baseline, Screening and 2 phone calls
  • 12 week drug titration (6 visits) and 5 phone calls
  • Approximately 1 year and 9 month Treatment period (7 visits)

Subjects will come in for visits approximately every two weeks for the first three months and then quarterly for the remainder of the study. Subjects' antiepileptic drug levels will be tested to monitor for drug interactions. Lab assessments (CBC, CMP, urinalysis) will be performed to monitor for changes in bone marrow, liver, and kidney function to ensure safe use.

Cannabidiol will be in the form of 100 mg/ml oral solution. Subjects will be given CBD to take in addition to their current anti-epileptic drug (AED) regimen.


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Study Type : Expanded Access
Official Title: Safety and Tolerability of Cannabidiol in Subjects With Drug Resistant Epilepsy

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy


Intervention Details:
  • Drug: Cannabidiol
    Formulation: 100mg/ml CBD (Epidiolex) Solution
    Other Name: Epidiolex

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ages 1-60 years of age.
  2. Patient must have at least 4 clinically countable seizures per month. They must also have prior concomitant video-EEG with evidence documenting a diagnosis of epilepsy. 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.
  3. Drug resistant epilepsy defined as a trial of at least four drugs, including one trial of a combination of two concomitant drugs, without successful seizure control. Vagal nerve stimulation, RNS deep brain stimulation, or the ketogenic diet can be considered equivalent to a drug trial and documented evidence of drug and other therapeutic failures.
  4. Between 1-4 baseline anti-epileptic drugs at time of enrollment. Vagus nerve stimulator (VNS), ketogenic diet and modified Atkins diet do not count toward this limit and are not contraindicated for inclusion.
  5. Subject and family sign assent (if capable)/consent/research authorization and are able to meet the study expectations for appointments for the duration of the study
  6. VNS, if in use must be on stable settings for a minimum of 1 month.
  7. If on ketogenic diet, must be on stable ratio for a minimum of 3 months.
  8. Patients or their caregivers must be able to consistently maintain a seizure diary for at least 2 months prior to enrollment and during the course of the study period.
  9. Must be Nebraska state resident.

Exclusion Criteria:

  1. Renal, hepatic, pancreatic, or hematologic dysfunction as evidenced by: values above upper limits of normal for BUN/creatinine, or values twice the upper limit of normal for serum transaminases (ALT/SGPT, AST/SGOT), values twice the upper limit of normal for serum lipase and amylase, platelets <80,000 /mcL, WBC<3.0 103 /mcL
  2. Less than 4 countable (non-countable seizures includes absence and myoclonic) seizures per month
  3. Use of cannabis-related product within last 30 days
  4. Active substance abuse/addiction.
  5. CBD is contraindicated in pregnancy and breastfeeding. 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 urine pregnancy test before entry into the study. Female subjects will be informed not to become pregnant while taking cannabidiol, and must agree to an acceptable method of barrier contraception use during the study which should include abstinence or a double barrier method for the duration of treatment.

    Female subjects must tell the investigator and consult an obstetrician or maternal-fetal specialist if they become pregnant during the study. If pregnancy occurs, CBD will be stopped in the most clinically appropriate manner.

  6. Allergy to CBD or any cannabinoid.
  7. Unable to provide consent (and no LAR available)
  8. Unable to comply with study visits/requirements.
  9. Use of alcohol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02660255


Sponsors and Collaborators
Christopher J. Kratochvil, M.D.
GW Pharmaceuticals Ltd.
Investigators
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Principal Investigator: Deepak Madhavan, MD University of Nebraska

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Responsible Party: Christopher J. Kratochvil, M.D., Associate Vice Chancellor & Chief Medical Officer for Vice Chancellor for Research, University of Nebraska Medical Center, University of Nebraska
ClinicalTrials.gov Identifier: NCT02660255     History of Changes
Other Study ID Numbers: 719-15-FB
First Posted: January 21, 2016    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019

Keywords provided by Christopher J. Kratochvil, M.D., University of Nebraska:
CBD
Epidiolex
Myoclonic
Brain Disease
Central Nervous System Disease
GWP42003

Additional relevant MeSH terms:
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Epilepsy
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epidiolex
Anticonvulsants