Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06401538
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-05-02
Brief Title:
BMB-101 in Absence Epilepsy and DEE
Sponsor:
Bright Minds Biosciences Pty Ltd
Organization:
Bright Minds Biosciences Pty Ltd
Study Overview
Official Title:
An Open-Label Phase 2 Study to Evaluate the Efficacy Safety and Tolerability of BMB-101 in Adults With Either Classic Absence Epilepsy With or Without Eyelid Myoclonia EEM Jeavons Syndrome OR Developmental Epileptic Encephalopathy DEE
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
The study is a pilot open-label study to test whether BMB-101 is safe and effective in reducing the frequency of seizures in subjects with Absence Epilepsy including Epilepsy with Eyelid Myoclonia also called Jeavons Syndrome as well as Developmental Epileptic Encephalopathies such as Dravet and Lennox Gastaut The study will last up to 6 months There will be a 1 month screening period then up to 3 months on open-label BMB-101 including titration and taperingwashout periods and then a 1 month follow-up period There will be 6 clinic visits
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None