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]. (NCT06401538)

The aim of this study is 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). A maximum of 20 participants will participate. Male or females, aged 18-65 yrs. Study duration is 4-5 months. For participants with classic absence epilepsy, there will be a 1-month screening period, then 8 weeks on BMB-101, and then a 1-month follow-up period. There will be 5 clinic visits and at least 4 phone calls. For participants with DEE, there will be a 1-month screening period, then 12 weeks on BMB-101, and then a 1-month follow-up period. There will be 6 clinic visits and at least 3 phone calls. The goal of the study is to assess the effects of BMB-101 in reducing the number of seizures. This will be done by comparing the frequency of seizures on EEGs and participant diaries.

Trial phase

Phase 2

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Prof Terence O'Brien

Key inclusion data

The main inclusion criteria include but are not limited to the following: 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. Subjects with Absence must experience at least 4 occurrences 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 a routine 24 hour EEG and experience at least 4 seizures during the 4 week baseline period prior to BMB-101 administration. 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 current anti-seizure medications for at least 4 weeks prior to baseline and remain stable throughout the study.