Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMB-101 | Experimental | BMB-101 10 mg/ml liquid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMB-101 | Drug | BMB-101 liquid administered orally twice a day for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in seizure frequency in DEE subjects | Seizure diary | 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 | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in quality of life | Quality of Life in Epilepsy (QOLIE-31) for adults | 6-10 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachelle Kirk-Burnnand | Contact | +61 439615368 | rachelle@basebio.com.au |
| Name | Affiliation | Role |
|---|---|---|
| Terence O'Brien, MD | The Alfred | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Prince of Wales Hospital | Recruiting | Randwick | New South Wales | 2031 | Australia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004832 | Epilepsy, Absence |
| D004831 | Epilepsies, Myoclonic |
| D065768 | Lennox Gastaut Syndrome |
| ID | Term |
|---|---|
| D004829 | Epilepsy, Generalized |
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Royal Brisbane and Womans Hospital | Recruiting | Herston | Queensland | 4029 | Australia |
|
| St Vincent's Hospital Melbourne | Recruiting | Fitzroy | Victoria | 3065 | Australia |
|
| Austin Health | Recruiting | Heidelberg | Victoria | 3084 | Australia |
|
| Alfred Health | Recruiting | Melbourne | Victoria | 3004 | Australia |
|
| D009422 |
| Nervous System Diseases |
| D000073376 | Epileptic Syndromes |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |