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Cannabidiol (CBD) and Pediatric Epilepsy

This study is currently recruiting participants.
Verified September 2017 by University of Colorado, Denver
Sponsor:
ClinicalTrials.gov Identifier:
NCT02447198
First Posted: May 18, 2015
Last Update Posted: September 20, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Colorado, Denver
  Purpose

Legislation to allow medical marijuana has had a significant impact on the pediatric population of Colorado. There have been many reported different effects and properties of each of the over 60 known cannabinoids found in marijuana. The main exposures in pediatrics have involved the use of Cannabidiol (CBD) high- and Tetrahydrocannibinol (THC) low-content hash oil in children with epilepsy. The reported benefit of this oil is to have the anticonvulsant properties of CBD without the psychoactive components of THC. Human studies on the efficacy of CBD on epilepsy are few and limited.

The investigators' specific aims are the following:

  • Specific Aim 1: Describe the plasma pharmacokinetics of Cannabidiol (CBD), Tetrahydrocannibinol (THC), and their respective metabolites in pediatric patients with epilepsy.
  • Specific Aim 2: Describe the plasma pharmacokinetics of other antiepileptic drugs (AEDs) taken in conjunction with CBD in order to evaluate drug interactions.
  • Specific Aim 3: Describe parental perception of efficacy of CBD on control of epilepsy.

The investigators will recruit children and their parents who are currently using or plan to use CBD for their seizure disorder. This study will NOT be providing patients with CBD. Consenting subjects will undergo a number of blood and urine collection that will be analyzed to describe the pharmacokinetics and possible drug interactions of CBD in pediatric epilepsy.


Condition
Epilepsy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cannabidiol (CBD) and Pediatric Epilepsy

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Describe the plasma pharmacokinetics of Cannabidiol (CBD), other antiepileptic drugs, Tetrahydrocannibinol (THC), and their respective metabolites in pediatric patients with epilepsy. [ Time Frame: Change from baseline to 12 hours post CBD administration ]

    Blood samples will be obtained at 6 time periods: at baseline prior to the first dose of CBD and at the following time intervals after administration of CBD: 1 hour, 2 hour, 4 hour, 8 hour, and 12 hours after administration of CBD.

    Urine will be collected for first 8 hours to account for renal elimination of CBD and antiepileptics.



Secondary Outcome Measures:
  • Demographic Data [ Time Frame: collected once at study visit ]
  • Medication History [ Time Frame: collected once at study visit ]
  • CBD History [ Time Frame: collected once at study visit ]
  • Describe parental perception of efficacy of CBD on control of epilepsy [ Time Frame: collected once at study visit ]
    A parental survey will be completed.


Biospecimen Retention:   Samples Without DNA

Blood samples will be drawn up to 6 times. It will be centrifuged to collect the plasma. The plasma will be used to obtain concentration of cannabinols and anticonvulsant medications in order to perform pharmacokinetic calculations.

All urine output for the first 8 hours after initial CBD dose will be collected.


Estimated Enrollment: 300
Actual Study Start Date: November 2, 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   31 Days to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
We will recruit children and their parents who are currently using or plan to use CBD for their seizure disorder.
Criteria

Inclusion Criteria:

  • Patients > 1 month and < 18 years of age who use, or plan to use, orally administered CBD rich hash oil for treatment of epilepsy
  • Parent/legal guardian accompanying patient who is >= 18 year of age and non-incarcerated.

Exclusion Criteria:

  • Patients without epilepsy/seizure disorder as diagnosed by a neurologist
  • Have known abnormalities in liver (AST, ALT, INR above normal range), or kidney function (creatinine above normal range)
  • Patient is known to be pregnant at time of enrollment (however, guardians who may be pregnant can be included for survey completion)
  • Patient is ward of the state
  • Unable to provide verification of hash oil potency and content
  Contacts and Locations
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): NCT02447198


Contacts
Contact: George Sam Wang, MD 303-724-9967 george.wang@childrenscolorado.org
Contact: Kathleen Grice, BS 303-724-3285 kathleen.grice@childrenscolorado.org

Locations
United States, Colorado
Recruiting
Denver, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: George Sam Wang, MD University of Colorado, Denver
  More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02447198     History of Changes
Other Study ID Numbers: 15-0216
UL1TR001082 ( U.S. NIH Grant/Contract )
First Submitted: May 7, 2015
First Posted: May 18, 2015
Last Update Posted: September 20, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases