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NCT Number: NCT02447198

Cannabidiol (CBD) and Pediatric Epilepsy

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

31 day–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. Demographic Data

    Time frame: collected once at study visit

  2. Medication History

    Time frame: collected once at study visit

  3. CBD History

    Time frame: collected once at study visit

  4. Describe parental perception of efficacy of CBD on control of epilepsy

    Time frame: collected once at study visit

    A parental survey will be completed.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 18, 2015
Registry last updated
Oct 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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