Cannabidiol (CBD) and Pediatric Epilepsy
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Epilepsy |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | Any - 17 |
| Updated: | 11/1/2018 |
| Start Date: | November 2, 2015 |
| End Date: | September 11, 2018 |
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.
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.
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
We found this trial at
1
site
13123 E 16th Ave
Aurora, Colorado 80045
Aurora, Colorado 80045
(720) 777-1234
Phone: 303-724-3285
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