Actively Recruiting
Phase 2 Open-Label Study of BMB-101 for Adults with Absence Epilepsy, Jeavons Syndrome, or Developmental Epileptic Encephalopathies including Dravet and Lennox-Gastaut Syndromes
Led by Bright Minds Biosciences Pty Ltd · Updated on 2025-08-12
20
Participants Needed
5
Research Sites
10 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of BMB-101 in reducing seizure frequency in adults with Absence Epilepsy, including Epilepsy with Eyelid Myoclonia Jeavons Syndrome, as well as Developmental Epileptic Encephalopathies such as Dravet and Lennox-Gastaut syndromes. This open-label Phase 2 study will last up to six months and aims to better understand how BMB-101 may impact these conditions. Participants will take BMB-101 liquid orally twice daily for up to three months. The study includes a one-month screening period, followed by the treatment phase with dose adjustments titration and taperingwashout, and then a one-month follow-up period. There will be six clinic visits during the study to monitor progress and safety. Participants will be asked to complete seizure diaries and attend scheduled clinic visits for evaluations. Researchers will use 24-hour EEGs to measure changes in seizure activity and generalized spike-wave discharges, along with assessments of quality of life. The study will monitor safety, tolerability, and seizure frequency changes over a total participation period of about six months.
CONDITIONS
Brief 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 (Jeavons Syndrome), or Developmental and Epileptic Encephalopathy such as Dravet syndrome or Lennox-Gastaut syndrome or other DEE.
- For Absence Epilepsy, at least 4 episodes of 3-4/second spike-wave discharges lasting at least 3 seconds on 24-hour EEG during baseline.
- For DEE, typical EEG pattern and at least 4 seizures during the 4-week baseline period.
- Male or female aged 18 to 65 years at baseline.
- Tried at least one anti-seizure medication at recommended dose and duration and on stable dose for at least 4 weeks prior to baseline.
- Willing and able to comply with diary completion, visit schedule, and study drug accountability.
- Female subjects of childbearing potential must have negative urine pregnancy test at baseline.
- Willing to use medically acceptable birth control or abstinence during the study and for 90 days after last dose.
You will not qualify if you...
- Current or past cardiovascular or cerebrovascular disease including cardiac valvulopathy, pulmonary hypertension, myocardial infarction, stroke, or significant structural cardiac abnormality.
- Moderate or severe hepatic impairment; mild hepatic impairment may be allowed after review.
- Severe renal impairment (eGFR less than 30 mL/min/1.73m2).
- Clinically significant ECG abnormalities (QTcF >450 msec males, >470 msec females).
- Receiving certain medications such as fenfluramine, lorcaserin, MAO inhibitors, SSRIs, SNRIs, tricyclic antidepressants, or other serotonergic agents.
- Currently on another investigational medicinal product.
- Participation in another clinical trial within the last 30 days.
- History of drug or alcohol abuse within 12 months or positive drug screen (except cannabinoids).
- Current severe suicidal ideation or recent suicide attempt.
- Clinically significant illness or symptoms in 4 weeks prior to baseline other than epilepsy that could affect participation or safety.
Research Team
R
Rachelle Kirk-Burnnand
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here