NCT06401538

BMB-101 in Absence Epilepsy and DEE

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: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Bright Minds Biosciences Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	BMB-101	BMB-101 liquid administered orally twice a day for 3 months

Timeline

• Start date: 2024-12-05
• Primary completion: 2025-09-15
• Completion: 2025-11-30
• First posted: 2024-05-06
• Last updated: 2025-08-12

Locations

5 sites across 1 country: Australia