Cannabidiol (CBD) and Pediatric Epilepsy

Epilepsy Clinical Trial

Official title:

Cannabidiol (CBD) and Pediatric Epilepsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02447198
• Other study ID #: 15-0216
• Secondary ID: UL1TR001082
• Status: Completed
• Start date: November 2, 2015
• Est. completion date: September 11, 2018

Study information

• Verified date: October 2018
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 11, 2018
• Est. primary completion date: September 11, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 31 Days to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Describe the plasma pharmacokinetics of Cannabidiol (CBD), other antiepileptic drugs, Tetrahydrocannibinol (THC), and their respective metabolites in pediatric patients with epilepsy.	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.	Change from baseline to 12 hours post CBD administration
Secondary	Demographic Data		collected once at study visit
Secondary	Medication History		collected once at study visit
Secondary	CBD History		collected once at study visit
Secondary	Describe parental perception of efficacy of CBD on control of epilepsy	A parental survey will be completed.	collected once at study visit