BMB-101 in Absence Epilepsy and DEE
NCT06401538 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2025-08-12
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 tapering/washout periods, and then a 1 month follow-up period. There will be 6 clinic visits.
Conditions
- Absence Epilepsy
- Jeavons Syndrome
- Dravet Syndrome
- Lennox Gastaut Syndrome
Interventions
- DRUG
-
BMB-101
BMB-101 liquid administered orally twice a day for 3 months
Sponsors & Collaborators
-
Bright Minds Biosciences Pty Ltd
lead INDUSTRY
Principal Investigators
-
Terence O'Brien, MD · The Alfred
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-05
- Primary Completion
- 2025-09-15
- Completion
- 2025-11-30
Countries
- Australia
Study Locations
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