Clinical Trial: The Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in Children With Severe Epilepsy

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title:

Brief Summary: The investigators propose to study the effects of cannabidiol (CBD) on cardiac electrical function and the autonomic nervous system in children with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS), when the CBD is administered as an artisanal oil obtained through state dispensaries or other sources. The intent is to begin to assess potential risks and benefits of this therapy in a vulnerable patient population by characterizing the effects of CBD on EKG findings, heart rate variability and the occurrence of seizures.

Detailed Summary:

Specific Aims/Study Objectives

This is a pilot study to explore the effects of cannabidiol (CBD) on autonomic cardiac function in children with Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS) when the CBD is administered as an artisanal oil. This will be achieved by addressing the following specific aims.

Aim #1: To determine the effects of CBD on cardiac function in 30 children with DS and LGS. This is the primary aim of the study: The effects of CBD on the cardiac function of 30 children with DS or LGS will be assessed using a 15-lead electrocardiogram (EKG) and a 24-hour Holter monitor. Investigators hypothesize that there will be no alterations in ventricular repolarization and heart rate variability on the EKG and Holter monitoring, respectively, after taking CBD for 4-8 weeks, compared to when participants were not taking CBD.

Note: The following aims are secondary to the primary outcome and goal of assessing the effects of CBD on cardiac function.

Aim #2: To assess signs and symptoms of dysautonomia in the presence and absence of CBD. Signs and symptoms of dysautonomia include parental perception of body temperature, skin color in hands and feet, sweating, pupil size, flushing, feeding issues, heart rate, strong emotions, constipation, urination or bowel movement issues, and irritability. These signs and symptoms will be collected using a previously-established dysautonomia survey. Investigators hypothesize there will be no change in qualitative assessments of signs and symptoms of dysautonomia after taking CBD for 4-8 weeks, compared to when participants were not taking CBD.

Aim #3: To determine the effects of CBD on the occurrence of seizures. The number of sei
Sponsor: Gillette Children's Specialty Healthcare

Current Primary Outcome:

  • ECG parameters [ Time Frame: Baseline and 4 to 8 week follow up visit ]
    Compare baseline ECG QT interval and corrected QT interval using the Bazzett formula to follow up visit ECG QT and QTc parameters
  • Holter heart rate parameters [ Time Frame: Baseline and 4 to 8 week follow up visit ]
    Compare baseline Holter heart rate variability and time domain parameters ( RR interval, SDNN, and SDNN-i) and frequency domain parameters (VLF, HF, and LF amplitude) with follow up visit Holter heart rate parameters.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Seizure frequency [ Time Frame: Baseline and 4 to 8 week follow up visit ]
    Compare seizure frequency in those who began the study prior to taking cannabadiol with those already taking cannabadiol at baseline.
  • Dysautonomia signs and symptoms [ Time Frame: Baseline and 4 to 8 week follow up visit ]
    Compare the frequency per day/week of signs and symptoms of dysautonomia as documented on screening questionnaire when subjects are taking cannabadiol to when subjects were not taking cannabadiol.


Original Secondary Outcome: Same as current

Information By: Gillette Children's Specialty Healthcare

Dates:
Date Received: June 20, 2016
Date Started: June 2016
Date Completion: December 2017
Last Updated: June 23, 2016
Last Verified: June 2016