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Cannabidiol (CBD) and Pediatric Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02447198
Recruitment Status : Completed
First Posted : May 18, 2015
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date May 7, 2015
First Posted Date May 18, 2015
Last Update Posted Date October 30, 2018
Actual Study Start Date November 2, 2015
Actual Primary Completion Date September 11, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 13, 2015)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02447198 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 13, 2015)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cannabidiol (CBD) and Pediatric Epilepsy
Official Title Cannabidiol (CBD) and Pediatric Epilepsy
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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:

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.

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.
Condition Epilepsy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 12, 2018)
42
Original Estimated Enrollment
 (submitted: May 13, 2015)
300
Actual Study Completion Date September 11, 2018
Actual Primary Completion Date September 11, 2018   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 31 Days to 17 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02447198
Other Study ID Numbers 15-0216
UL1TR001082 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Colorado, Denver
Study Sponsor University of Colorado, Denver
Collaborators Not Provided
Investigators
Principal Investigator: George Sam Wang, MD University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date October 2018