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NCT02815540 · ClinicalTrials.gov registry record · Phase 1
The Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in Children With Severe Epilepsy
A Phase 1 study, sponsored by Gillette Children's Specialty Healthcare.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT02815540 is a Phase 1 study that was terminated before completion, run by Gillette Children's Specialty Healthcare. The registered enrollment target is 2 participants.
The verdict
NCT02815540, a Phase 1 study, was terminated before completion, sponsored by Gillette Children's Specialty Healthcare.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study 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.
Interventions
- DRUG Cannabidiol
- PROCEDURE 12-Lead ECG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2017-02-16 |
| Est. Completion | 2018-12-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02815540
The ClinicalTrials.gov registry entry for NCT02815540 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gillette Children's Specialty Healthcare, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cannabidiol is the first listed.
NCT02815540 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02815540 about?
NCT02815540 is a clinical study titled "The Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in Children With Severe Epilepsy". 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 s...
What is the current status of trial NCT02815540?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2017-02-16. Estimated completion is 2018-12-01.
What interventions are being tested in trial NCT02815540?
The interventions under investigation include: Cannabidiol (DRUG), 12-Lead ECG (PROCEDURE).
Who is sponsoring clinical trial NCT02815540?
This trial is sponsored by Gillette Children's Specialty Healthcare, which has 12 total clinical trials registered on ClinicalTrials.gov.
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