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BREAKTHROUGH Study: BMB-101 in Absence Epilepsy and DEE
NCT06401538Phase 2
Key facts
- Status
- Recruiting
- Start
- Dec 2024
- Primary completion
- Sep 2025
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- BMB-101
- Conditions
- absence epilepsyJeavons syndromedevelopmental and epileptic encephalopathy (DEE)Dravet syndromeLennox-Gastaut syndrome (LGS)
01
Overview
Phase 2, open-label, single-arm trial of BMB-101 in absence epilepsy, Jeavons syndrome, developmental and epileptic encephalopathy (DEE) and 2 more, sponsored by Bright Minds Biosciences Inc. Primary endpoints: Change from baseline in seizure frequency in DEE subjects at 10 weeks and Change from baseline in the number of generalized spike-wave discharges (GSWD) on the 24 hr EEG at 6 weeks. Started Dec 2024; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
BMB-101
BMB-101 oral liquid
03
Who it enrols
Adults with Absence Epilepsy (with/without Jeavons Syndrome) or DEE (Dravet, Lennox-Gastaut) who have failed at least one ASM and are on a stable regimen. Exclusion for significant cardiac, hepatic, or renal disease, or use of serotonergic drugs.
04
Endpoints
Primary
Change from baseline in seizure frequency in DEE subjects
Change from baseline in the number of generalized spike-wave discharges (GSWD) on the 24 hr EEG
Secondary
Change from baseline in quality of life
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