Cannabidiol (CBD) and Pediatric Epilepsy

NCT02447198 | Completed

• 2 other identifiers: 15-0216UL1TR001082
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Demographic Data

  collected once at study visit

• Medication History

  collected once at study visit

• CBD History

  collected once at study visit

• Describe parental perception of efficacy of CBD on control of epilepsy

  collected once at study visit

Eligibility Criteria

• Age: 31 Days - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

We will recruit children and their parents who are currently using or plan to use CBD for their seizure disorder.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• Wang GS, Bourne DWA, Klawitter J, Sempio C, Chapman K, Knupp K, Wempe MF, Borgelt L, Christians U, Leonard J, Heard K, Bajaj L. Disposition of Oral Cannabidiol-Rich Cannabis Extracts in Children with Epilepsy. Clin Pharmacokinet. 2020 Aug;59(8):1005-1012. doi: 10.1007/s40262-020-00869-z.

  PMID: 32048179 DERIVED

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.

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• George Sam Wang, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2015
• First Posted: May 18, 2015
• Study Start: November 2, 2015
• Primary Completion: September 11, 2018
• Study Completion: September 11, 2018
• Last Updated: October 30, 2018

Record last verified: 2018-10

Locations

US (1)