Cannabidiol (CBD) and Pediatric Epilepsy

Completed

• Conditions: Epilepsy

• Registration Number: NCT02447198
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-07
• Study First Submitted QC: 2015-05-13
• Study First Posted: 2015-05-18
• Study Start: 2015-11-02
• Primary Completion: 2018-09-11
• Study Completion: 2018-09-11
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-29
• Last Update Posted: 2018-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Describe the plasma pharmacokinetics of Cannabidiol (CBD), other antiepileptic drugs, Tetrahydrocannibinol (THC), and their respective metabolites in pediatric patients with epilepsy.	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

Name	Time	Method
Demographic Data	collected once at study visit
CBD History	collected once at study visit
Medication History	collected once at study visit
Describe parental perception of efficacy of CBD on control of epilepsy	collected once at study visit	A parental survey will be completed.

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States