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NCT02447198 · ClinicalTrials.gov registry record
Cannabidiol (CBD) and Pediatric Epilepsy
A clinical trial, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- 42
- Enrollment target
NCT02447198: Completed study, sponsored by University of Colorado, Denver.
NCT02447198 is a clinical trial that has completed, run by University of Colorado, Denver. The registered enrollment target is 42 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02447198 has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- 42 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2015-11-02 |
| Est. Completion | 2018-09-11 |
What the finished NCT02447198 record still lists
NCT02447198 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 42 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02447198 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02447198 about?
NCT02447198 is a clinical study titled "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 Cannabid...
What is the current status of trial NCT02447198?
This trial is currently completed. The enrollment target is 42 participants. The study started on 2015-11-02. Estimated completion is 2018-09-11.
Who is sponsoring clinical trial NCT02447198?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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