Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2025-12-27 @ 2:48 AM
Study NCT ID:
NCT04899050
Status:
COMPLETED
Last Update Posted:
2023-07-11
First Post:
2021-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidiolex in Typical Absence Seizures
Sponsor:
University of South Florida
Organization:
Study Overview
Official Title:
Safety and Efficacy of CBD (Epidiolex) in Idiopathic Generalized Epilepsy With Typical Absence Seizures
Status:
COMPLETED
Status Verified Date:
2023-07
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:
None
Brief Summary:
This is a Pilot study, open-label study consisting of a screening period of up to 4 weeks, a 4-week dose-titration treatment period to dose of up to 20 mg/kg/day BID of CBD (Epidiolex), and a 30 day safety follow-up period following the last dose of study medication.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
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?: