Clinical trial NCT02447198: Cannabidiol (CBD) and Pediatric Epilepsy
Official title: Cannabidiol (CBD) and Pediatric Epilepsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2015-05-18
Enrollment: 42
Sex: ALL
Minimum age (years): 31
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Describe the plasma pharmacokinetics of Cannabidiol (CBD), other antiepileptic drugs, Tetrahydrocannibinol (THC), and their respective metabolites in pediatric patients with epilepsy.
timeFrame: Change from baseline to 12 hours post CBD administration
Secondary outcomes:
measure: Demographic Data
timeFrame: collected once at study visit
measure: Medication History
timeFrame: collected once at study visit
measure: CBD History
timeFrame: collected once at study visit
measure: Describe parental perception of efficacy of CBD on control of epilepsy
timeFrame: collected once at study visit
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: George Sam Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang GS, Bourne DWA, Klawitter J, Sempio C, Chapman K, Knupp K, Wempe MF, Borgelt L, Christians U, Leonard J, Heard K, Bajaj L. Disposition of Oral Cannabidiol-Rich Cannabis Extracts in Children with Epilepsy. Clin Pharmacokinet. 2020 Aug;59(8):1005-1012. doi: 10.1007/s40262-020-00869-z.