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Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
ID06401538

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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