Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT06924827
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-24
First Post:
2025-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Transition of Children From 'Artisanal" Cannabidiol (CBD) to Epidiolex
Sponsor:
Elizabeth Donner
Organization:
Study Overview
Official Title:
A Clinical Study of the Transition of Children From 'Artisanal' Cannabidiol to Epidiolex
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CANN-SWITCH
Brief Summary:
The goal of this clinical trial is to learn the best way to switch children with Lennox-Gastaut Syndrome (LGS) or Dravet Syndrome (DS) taking 'artisanal' (non pharmaceutical-grade) cannabidiol (CBD) to Epidiolex for treatment of seizures. The main questions it aims to answer are:
* How well does a gradual switch from 'artisanal' CBD to Epidiolex work?
* Does the same dose of Epidiolex as 'artisanal' CBD work best?
* What side-effects or medical problems do participants have when switching from 'artisanal' CBD to Epidiolex?
Researchers will examine how successful switching from 'artisanal' CBD to Epidiolex is.
Participants will:
* Gradually increase their dose of Epidiolex and reduce their dose of 'artisanal' CBD until they are taking just Epidiolex
* Visit the clinic five times over 20 weeks for checkups and tests
* Keep a diary of their seizures, symptoms and the number of times they use a rescue seizure medication
* How well does a gradual switch from 'artisanal' CBD to Epidiolex work?
* Does the same dose of Epidiolex as 'artisanal' CBD work best?
* What side-effects or medical problems do participants have when switching from 'artisanal' CBD to Epidiolex?
Researchers will examine how successful switching from 'artisanal' CBD to Epidiolex is.
Participants will:
* Gradually increase their dose of Epidiolex and reduce their dose of 'artisanal' CBD until they are taking just Epidiolex
* Visit the clinic five times over 20 weeks for checkups and tests
* Keep a diary of their seizures, symptoms and the number of times they use a rescue seizure medication
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: