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The Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in Children With Severe Epilepsy (CBD1)

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ClinicalTrials.gov Identifier: NCT02815540
Recruitment Status : Terminated (Investigator on medical leave, and difficult recruitment)
First Posted : June 28, 2016
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
Gillette Children's Specialty Healthcare

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.

Condition or disease Intervention/treatment Phase
Lennox-Gastaut Syndrome Dravet Syndrome Procedure: 12-Lead ECG Drug: Cannabidiol Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in Children
Actual Study Start Date : February 16, 2017
Actual Primary Completion Date : December 1, 2018
Actual Study Completion Date : December 1, 2018


Arm Intervention/treatment
Observational
This study looks at participants already receiving CBD from the state of MN. We are not providing the CBD. We are looking at heart function with ECGs and Holter monitoring before and after CBD is taken by the participant. We are also looking at dysautonomia signs and symptoms and seizure frequency before and after CBD is taken by the participant.
Procedure: 12-Lead ECG
Subjects will be monitored while on cannabidiol with a 12-Lead ECG and/or Holter monitoring
Other Name: Holter Monitor

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




Primary Outcome Measures :
  1. Holter SDNN parameter change [ Time Frame: Baseline to 4 to 8 week follow up visit ]
    Change from baseline Holter SDNN parameter to follow up visit Holter SDNN parameter.


Secondary Outcome Measures :
  1. Seizure frequency [ Time Frame: Baseline and 4 to 8 week follow up visit ]
    Change from baseline seizure frequency to follow up visit seizure frequency.

  2. Dysautonomia signs and symptoms [ Time Frame: Baseline and 4 to 8 week follow up visit ]
    signs and symptoms assessed by questionnaire developed for this study that documents observable signs and symptoms of dysautonomia



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Ages Eligible for Study:   2 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with Dravet syndrome or Lennox-Gastaut syndrome
  • Patients who are planning to obtain medical cannabidiol
  • Patients who are already taking medical cannabidiol and are planning to stop taking it

Exclusion Criteria:

  • Patients without a diagnosis of Dravet syndrome or Lennox-Gastaut syndrome

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02815540


Locations
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United States, Minnesota
Gillette Children's Specialty Healthcare
Saint Paul, Minnesota, United States, 55101
Sponsors and Collaborators
Gillette Children's Specialty Healthcare

Publications:
1. Dravet C, Bureau M, Oguni H, Fukuyama Y, Cokar O. Severe myoclonic epilepsy in infancy (Dravet syndrome). In: Roger J, Bureau M, Dravet C, Genton P, Tassinari CA, Wolf P (eds) Epileptic syndromes in infancy, childhood and adolescence, 4th ed. John Libbey, London, 2005, pp 89 - 109.
2. http://www.ninds.nih.gov/disorders/lennoxgastautsyndrome/lennoxgastautsyndrome.htm, Retrieved 6.10.2015
7. Wical, B, Wendorf H, Leighty D, Tervo M, Tervo R. Signs of Dysautonomia in Children with Dravet Syndrome. Presented at the Annual Meeting of the American Epilepsy Society, Boston, MA, Dec 2009.
15. Ohlsson A, Lindgren JE, Andersson S, Agurell S, Gillespie H, Hollister L. (1984). Single dose kinetics of cannabidiol in man. Cannabinoids: chemical, pharmacologic, and therapeutic aspects. S. Agurell, W. L. Dewey and R. Willette. Orlando, FL, Academic Press Inc.: 219-225. doi: 10.1016/B978-0-12-044620-9.50003-8

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Responsible Party: Gillette Children's Specialty Healthcare
ClinicalTrials.gov Identifier: NCT02815540     History of Changes
Other Study ID Numbers: CBD-001
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Epidiolex
Syndrome
Lennox Gastaut Syndrome
Epilepsies, Myoclonic
Disease
Pathologic Processes
Epileptic Syndromes
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Epilepsy, Generalized
Anticonvulsants