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 : February 12, 2021
|Condition or disease||Intervention/treatment||Phase|
|Lennox-Gastaut Syndrome Dravet Syndrome||Procedure: 12-Lead ECG Drug: Cannabidiol||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
Subjects who are planning to take state dispensed medical cannabidiol, or are already taking state dispensed medical cannabidiol.
- 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.
- Seizure frequency [ Time Frame: Baseline and 4 to 8 week follow up visit ]Change from baseline seizure frequency to follow up visit seizure frequency.
- 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
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
|United States, Minnesota|
|Gillette Children's Specialty Healthcare|
|Saint Paul, Minnesota, United States, 55101|
|Principal Investigator:||Beverly S Wical, MD||Gillette Children's Specialty Healthcare|