Cannabidiol (CBD) and Pediatric Epilepsy | NCT02447198

Studies
Cannabidiol (CBD) and Pediatric Epilepsy

NCT02447198

Sponsor

University of Colorado, Denver

Status

Completed

Last Update Posted

Oct 30, 2018Actual

Enrollment

42Actual

Phase

Not provided

Conditions

Epilepsy

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
UL1TR001082	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2, 2015Actual

Primary Completion Date

Sep 11, 2018Actual

Completion Date

Sep 11, 2018Actual

First Submitted Date

May 7, 2015

First Submission Date that Met QC Criteria

May 13, 2015

First Posted Date

May 18, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 29, 2018

Last Update Posted Date

Oct 30, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

42Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Demographic Data		collected once at study visit
Medication History		collected once at study visit
CBD History

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

31 Days

Maximum Age

17 Years

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
George Sam Wang, MD	University of Colorado, Denver	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital Colorado		Aurora	Colorado	80045	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32048179	Derived	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.

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases