Actively Recruiting
Phase 2 Open-Label Study of BMB-101 for Adults with Absence Epilepsy, Jeavons Syndrome, or Developmental Epileptic Encephalopathies including Dravet and Lennox-Gastaut Syndromes
Led by Bright Minds Biosciences Pty Ltd · Updated on 2025-08-12
20
Participants Needed
5
Research Sites
10 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of BMB-101 in reducing seizure frequency in adults with Absence Epilepsy, including Epilepsy with Eyelid Myoclonia Jeavons Syndrome, as well as Developmental Epileptic Encephalopathies such as Dravet and Lennox-Gastaut syndromes. This open-label Phase 2 study will last up to six months and aims to better understand how BMB-101 may impact these conditions. Participants will take BMB-101 liquid orally twice daily for up to three months. The study includes a one-month screening period, followed by the treatment phase with dose adjustments titration and taperingwashout, and then a one-month follow-up period. There will be six clinic visits during the study to monitor progress and safety. Participants will be asked to complete seizure diaries and attend scheduled clinic visits for evaluations. Researchers will use 24-hour EEGs to measure changes in seizure activity and generalized spike-wave discharges, along with assessments of quality of life. The study will monitor safety, tolerability, and seizure frequency changes over a total participation period of about six months.
CONDITIONS
Brief Title
BMB-101 in Absence Epilepsy and DEE
Research Team
R
Rachelle Kirk-Burnnand
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