NCT02815540

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

February 16, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

January 3, 2022

Completed
Last Updated

August 30, 2022

Status Verified

August 1, 2022

Enrollment Period

1.8 years

First QC Date

June 20, 2016

Results QC Date

December 2, 2021

Last Update Submit

August 2, 2022

Conditions

Lennox-Gastaut SyndromeDravet Syndrome

Outcome Measures

Primary Outcomes (1)

  • Holter SDNN Parameter Change

    Change from baseline Holter SDNN parameter to follow up visit Holter SDNN parameter.

    Baseline to 4 to 8 week follow up visit

Secondary Outcomes (2)

  • Seizure Frequency

    Baseline and 4 to 8 week follow up visit

  • Dysautonomia Signs and Symptoms

    Baseline and 4 to 8 week follow up visit

Study Arms (1)

Heart Function and Dysautonomia

OTHER

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 ECGDrug: Cannabidiol

Interventions

12-Lead ECGPROCEDURE

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

Also known as: Holter Monitor
Heart Function and Dysautonomia
CannabidiolDRUG

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

Heart Function and Dysautonomia

Eligibility Criteria

Age2 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gillette Children's Specialty Healthcare

Saint Paul, Minnesota, 55101, United States

Location

Related Publications (15)

  • 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.

    BACKGROUND

  • 2. http://www.ninds.nih.gov/disorders/lennoxgastautsyndrome/lennoxgastautsyndrome.htm, Retrieved 6.10.2015

    BACKGROUND

  • Sakauchi M, Oguni H, Kato I, Osawa M, Hirose S, Kaneko S, Takahashi Y, Takayama R, Fujiwara T. Mortality in Dravet syndrome: search for risk factors in Japanese patients. Epilepsia. 2011 Apr;52 Suppl 2:50-4. doi: 10.1111/j.1528-1167.2011.03002.x.

    PMID: 21463280BACKGROUND

  • Skluzacek JV, Watts KP, Parsy O, Wical B, Camfield P. Dravet syndrome and parent associations: the IDEA League experience with comorbid conditions, mortality, management, adaptation, and grief. Epilepsia. 2011 Apr;52 Suppl 2:95-101. doi: 10.1111/j.1528-1167.2011.03012.x.

    PMID: 21463290BACKGROUND

  • Jehi L. Sudden death in epilepsy, surgery, and seizure outcomes: the interface between heart and brain. Cleve Clin J Med. 2010 Jul;77 Suppl 3:S51-5. doi: 10.3949/ccjm.77.s3.09.

    PMID: 20622077BACKGROUND

  • Kalume F. Sudden unexpected death in Dravet syndrome: respiratory and other physiological dysfunctions. Respir Physiol Neurobiol. 2013 Nov 1;189(2):324-8. doi: 10.1016/j.resp.2013.06.026. Epub 2013 Jul 9.

    PMID: 23850567BACKGROUND

  • 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.

    BACKGROUND

  • Delogu AB, Spinelli A, Battaglia D, Dravet C, De Nisco A, Saracino A, Romagnoli C, Lanza GA, Crea F. Electrical and autonomic cardiac function in patients with Dravet syndrome. Epilepsia. 2011 Apr;52 Suppl 2:55-8. doi: 10.1111/j.1528-1167.2011.03003.x.

    PMID: 21463281BACKGROUND

  • Nei M, Sperling MR, Mintzer S, Ho RT. Long-term cardiac rhythm and repolarization abnormalities in refractory focal and generalized epilepsy. Epilepsia. 2012 Aug;53(8):e137-40. doi: 10.1111/j.1528-1167.2012.03561.x. Epub 2012 Jun 18.

    PMID: 22709423BACKGROUND

  • Ergul Y, Ekici B, Tatli B, Nisli K, Ozmen M. QT and P wave dispersion and heart rate variability in patients with Dravet syndrome. Acta Neurol Belg. 2013 Jun;113(2):161-6. doi: 10.1007/s13760-012-0140-z. Epub 2012 Oct 13.

    PMID: 23065439BACKGROUND

  • Granjeiro EM, Gomes FV, Guimaraes FS, Correa FM, Resstel LB. Effects of intracisternal administration of cannabidiol on the cardiovascular and behavioral responses to acute restraint stress. Pharmacol Biochem Behav. 2011 Oct;99(4):743-8. doi: 10.1016/j.pbb.2011.06.027. Epub 2011 Jul 12.

    PMID: 21771609BACKGROUND

  • Bergamaschi MM, Queiroz RH, Chagas MH, de Oliveira DC, De Martinis BS, Kapczinski F, Quevedo J, Roesler R, Schroder N, Nardi AE, Martin-Santos R, Hallak JE, Zuardi AW, Crippa JA. Cannabidiol reduces the anxiety induced by simulated public speaking in treatment-naive social phobia patients. Neuropsychopharmacology. 2011 May;36(6):1219-26. doi: 10.1038/npp.2011.6. Epub 2011 Feb 9.

    PMID: 21307846BACKGROUND

  • Martin-Santos R, Crippa JA, Batalla A, Bhattacharyya S, Atakan Z, Borgwardt S, Allen P, Seal M, Langohr K, Farre M, Zuardi AW, McGuire PK. Acute effects of a single, oral dose of d9-tetrahydrocannabinol (THC) and cannabidiol (CBD) administration in healthy volunteers. Curr Pharm Des. 2012;18(32):4966-79. doi: 10.2174/138161212802884780.

    PMID: 22716148BACKGROUND

  • Gloss D, Vickrey B. Cannabinoids for epilepsy. Cochrane Database Syst Rev. 2014 Mar 5;2014(3):CD009270. doi: 10.1002/14651858.CD009270.pub3.

    PMID: 24595491BACKGROUND

  • 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

    BACKGROUND

MeSH Terms

Conditions

Lennox Gastaut SyndromeEpilepsies, Myoclonic

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Epileptic SyndromesEpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEpilepsy, Generalized

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Limitations and Caveats

Physician left institution and study was discontinued due to no other investigators available. No outcome measures were collected or analyzed.

Results Point of Contact

Title
Director of Research
Organization
Gillette Children's Specialty Healthcare
Research@gillettechildrens.com
651-229-1745

Study Officials

  • Beverly S Wical, MD

    Gillette Children's Specialty Healthcare

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2016

First Posted

June 28, 2016

Study Start

February 16, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

August 30, 2022

Results First Posted

January 3, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)