BMB-101 in Absence Epilepsy and DEE
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
| Condition(s) | Absence Epilepsy, Jeavons Syndrome, Dravet Syndrome, Lennox Gastaut Syndrome |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: 1. Subjects must have a diagnosis of Absence Epilepsy with or without eyelid myoclonia (Jeavons Syndrome) or a diagnosis of Developmental and Epileptic Encephalopathy (DEE) such as Dravet syndrome or Lennox-Gastaut syndrome or other DEE. 2. Subjects with Absence must experience at least 4 episodes of 3-4/second SWD lasting at least 3 seconds each in a 24 hour EEG during the baseline period. Those with DEE must have a typical EEG pattern for DEE on routine EEG and experience at least 4 seizures during the 4 week baseline period prior to BMB-101 administration. 3. Subjects can be male or female ages 18-65 inclusive at time of baseline. 4. Subject must have tried at least one anti-seizure medication at a recommended dose and duration and must be on a stable dose on their c |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | Bright Minds Biosciences Pty Ltd |
| Locations | Randwick, New South Wales, Australia; Herston, Queensland, Australia; Fitzroy, Victoria, Australia; Heidelberg, Victoria, Australia; Melbourne, Victoria, Australia |
| Start date | 2024-12-05 |
| NCT ID | NCT06401538 |
| Official listing | https://clinicaltrials.gov/study/NCT06401538 |