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

NCT02815540 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2022-08-30

Study results available
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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.

Conditions

Interventions

PROCEDURE

12-Lead ECG

Subjects will be monitored while on cannabidiol with a 12-Lead ECG and/or Holter monitoring

DRUG

Cannabidiol

Subjects who are planning to take state dispensed medical cannabidiol, or are already taking state dispensed medical cannabidiol.

Sponsors & Collaborators

  • Gillette Children's Specialty Healthcare

    lead OTHER

Principal Investigators

  • Beverly S Wical, MD · Gillette Children's Specialty Healthcare

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-16
Primary Completion
2018-12-01
Completion
2018-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02815540 on ClinicalTrials.gov