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

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Brief Title

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

Official Title

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

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.
    

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.
    


Study Type

Observational


Primary Outcome

Reduction in seizures

Secondary Outcome

 Cannabidiol concentration

Condition

Dravet Syndrome



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

0

Start Date

September 2016

Completion Date

December 31, 2017

Primary Completion Date

December 31, 2017

Eligibility Criteria

        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
      

Gender

All

Ages

2 Years - 30 Years

Accepts Healthy Volunteers

No

Contacts

Samuel A Roiko, Ph.D., , 



Administrative Informations


NCT ID

NCT02910297

Organization ID

CBD-PK-1


Responsible Party

Sponsor

Study Sponsor

Gillette Children's Specialty Healthcare

Collaborators

 University of Minnesota

Study Sponsor

Samuel A Roiko, Ph.D., Principal Investigator, Gillette Children's Specialty Healthcare


Verification Date

December 2021