Actively Recruiting
BMB-101 in Absence Epilepsy and DEE
Led by Bright Minds Biosciences Pty Ltd · Updated on 2025-08-12
20
Participants Needed
5
Research Sites
51 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
BMB-101 in Absence Epilepsy and DEE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Absence Epilepsy (with or without eyelid myoclonia) or Developmental Epileptic Encephalopathy including Dravet or Lennox Gastaut syndromes
- For Absence Epilepsy, at least 4 episodes of 3-4/second spike-wave discharges lasting 3 seconds each in 24-hour EEG baseline
- For DEE, typical EEG pattern and at least 4 seizures in 4 weeks before starting BMB-101
- Male or female aged 18 to 65 years at baseline
- Tried at least one anti-seizure medication and stable dose for at least 4 weeks prior and during study
- Willing and able to comply with diary, visit schedule, and study drug accountability
- Female participants of childbearing potential must have a negative pregnancy test at baseline
- Participants of childbearing or child-fathering potential must agree to use medically acceptable birth control during the study and for 90 days after last dose
You will not qualify if you...
- History or presence of cardiovascular or cerebrovascular disease (e.g., valvulopathy, pulmonary hypertension, heart attack, stroke, or significant heart abnormality)
- Moderate or severe liver impairment (mild liver impairment may be allowed after review)
- Severe kidney impairment (eGFR less than 30 mL/min/1.73m2)
- Significant ECG abnormalities (QTcF over 450 msec for males or over 470 msec for females)
- Currently taking fenfluramine, lorcaserin, monoamine-oxidase inhibitors, SSRIs, SNRIs, tricyclic antidepressants, or other serotonergic drugs
- Currently receiving another investigational drug
- Participated in another clinical trial within the last 30 days
- History of drug or alcohol abuse in past 12 months or positive urine drug screen (except cannabinoids)
- Current high suicide risk as indicated by C-SSRS score or suicide attempt in past year
- Any significant illness or symptoms in 4 weeks before baseline other than epilepsy that may affect participation or safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
The Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Actively Recruiting
2
Royal Brisbane and Womans Hospital
Herston, Queensland, Australia, 4029
Actively Recruiting
3
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia, 3065
Actively Recruiting
4
Austin Health
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
5
Alfred Health
Melbourne, Victoria, Australia, 3004
Actively Recruiting
Research Team
R
Rachelle Kirk-Burnnand
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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