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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
BMB-101 liquid administered orally twice a day for 3 months
The Prince of Wales Hospital
Randwick, New South Wales, Australia
RECRUITINGRoyal Brisbane and Womans Hospital
Herston, Queensland, Australia
RECRUITINGSt Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
RECRUITINGAustin Health
Heidelberg, Victoria, Australia
RECRUITINGAlfred Health
Melbourne, Victoria, Australia
RECRUITINGChange from baseline in seizure frequency in DEE subjects
Seizure diary
Time frame: 10 weeks
Change from baseline in the number of generalized spike-wave discharges (GSWD) on the 24 hr EEG in Absence subjects.
24 hour EEG
Time frame: 6 weeks
Change from baseline in quality of life
Quality of Life in Epilepsy (QOLIE-31) for adults
Time frame: 6-10 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.