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The Pharmacokinetics of Cannabidiol (CBD) and Its Effects in Children With Severe Epilepsy

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. Identifier: NCT02910297
Recruitment Status : Withdrawn (unable to recruit enough subjects on CBD)
First Posted : September 22, 2016
Last Update Posted : February 26, 2019
University of Minnesota
Information provided by (Responsible Party):
Gillette Children's Specialty Healthcare

Brief Summary:
The purpose of this study is to determine if cannabidiol (CBD) obtained via the state of Minnesota reduces seizures in patients with severe intractable epilepsy (Dravet Syndrome or Lennox Gastaut Syndrome), and to measure blood levels of CBD to help determine CBD concentration-response characteristics.

Condition or disease
Dravet Syndrome Lennox Gastaut Syndrome

Detailed Description:

Patients with medically refractory epilepsy who are registering to take CBD in the State of Minnesota will be offered the opportunity to participate in this study. If consent to participation is obtained, the patient (or more likely, the patient's guardian) will be asked to begin a seizure diary for at least a 7-day period prior (ideally, longer) to receiving the CBD, and to continue tracking seizures throughout the study. Upon receipt of CBD from the Minnesota dispensary, subjects will take their CBD as directed and will return to the clinic for a repeat visit (which is part of standard care) occurring 2-8 weeks after continual use of CBD. During these clinic visits, patients undergo blood draws to monitor their other prescribed AED concentrations as part of standard of care. In addition to the standard blood draw, the research participant will be asked to provide a blood sample of 5 ml to measure CBD concentrations. As most patients are instructed to take CBD two hours prior to their standard of care AEDs, clinical experience indicates that most patients are taking CBD quite early in the morning (around 6 AM). Thus, the time of sample collection will be recorded as hours post-dose, and will likely be nearer peak serum concentrations. If a study participant has an indwelling intravenous access port, they will be asked to provide an additional sample of 5 ml at least one hour after the initial sample. During the repeat visit, subjects will be asked to continue documenting seizure activity in their seizure diary while they continue their CBD treatment. Any changes to AEDs administered concurrently with CBD will also be recorded.

Subjects who are already on a stable regimen of CBD will also be eligible to participate. At a clinic visit, they will be asked to provide a blood sample of 5 ml, the time of each sample will be recorded as hours post-dose of CBD. They will also be asked to begin a seizure diary and continue tracking seizure activity. If a patient terminates their CBD treatment, they will be asked to continue tracking seizure activity after their last CBD dose until their follow-up clinic visit, to determine change in seizure activity while on and off CBD.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Actual Study Start Date : September 2016
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Primary Outcome Measures :
  1. Reduction in seizures [ Time Frame: a 7-day seizure diary completed at least twice within 3 months ]
    Subjects or parents/guardians of subjects will record seizure activity in seizure diaries both prior to and during cannabidiol administration

Secondary Outcome Measures :
  1. Cannabidiol concentration [ Time Frame: 1 time at a clinic visit within three months. If a patient has a port, they will be asked to provide an additional blood sample of 5 ml at least one hour after the first sample during the same clinic visit. ]
    Each subject will provide a blood sample of 5 ml to measure concentrations of cannabidiol

Biospecimen Retention:   Samples Without DNA
Blood samples collected to measure cannabidiol concentrations

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who have registered or plan to register with the state of Minnesota for taking medical cannabis and have severe intractable epilepsy (Dravet Syndrome or Lennox Gastaut Syndrome)

Inclusion Criteria:

  • Diagnosed with Dravet Syndrome or Lennox-Gastaut Syndrome
  • Patients who are planning to obtain medical cannabidiol
  • Patients who are already taking medical cannabidiol and are planning to stop taking it.

Exclusion Criteria:

  • Patients without a diagnosis of Dravet syndrome or Lennox-Gastaut syndrome

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Responsible Party: Gillette Children's Specialty Healthcare Identifier: NCT02910297    
Other Study ID Numbers: CBD-PK-1
First Posted: September 22, 2016    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Keywords provided by Gillette Children's Specialty Healthcare:
Dravet Syndrome
Lennox Gastaut Syndrome
Additional relevant MeSH terms:
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Lennox Gastaut Syndrome
Epilepsies, Myoclonic
Pathologic Processes
Epileptic Syndromes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Epilepsy, Generalized