Cannabidiol (CBD) and Pediatric Epilepsy
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|ClinicalTrials.gov Identifier: NCT02447198|
Recruitment Status : Recruiting
First Posted : May 18, 2015
Last Update Posted : September 20, 2017
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 or disease|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Cannabidiol (CBD) and Pediatric Epilepsy|
|Actual Study Start Date :||November 2, 2015|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||December 2018|
- 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.
- 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.
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
|Contact: George Sam Wang, MDfirstname.lastname@example.org|
|Contact: Kathleen Grice, BSemail@example.com|
|United States, Colorado|
|Denver, Colorado, United States, 80045|
|Principal Investigator:||George Sam Wang, MD||University of Colorado, Denver|