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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: Clinical Trial Phase 1 study, sponsored by Gillette Children's Specialty Healthcare.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change from baseline Holter SDNN parameter to follow up visit Holter SDNN parameter.
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 |
Why NCT02815540 stopped before completion
NCT02815540 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Cannabidiol is the first listed.
NCT02815540 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02815540's enrollment target sits among peer trials
2 2000th of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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