Absence EpilepsyPhase 2NCT06401538
BMB-101 in Absence Epilepsy and DEE
A Phase 2 study testing BMB-101 in people with Absence Epilepsy and Jeavons Syndrome, run by Bright Minds Biosciences Pty Ltd at 5 sites in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Absence Epilepsy, Jeavons Syndrome, Dravet Syndrome
- What is being tested?
- BMB-101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 5 sitesAustralia
- Study dates
- 5 Dec 2024to 30 Nov 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have a diagnosis of Absence Epilepsy with or without eyelid myoclonia (Jeavons Syndrome) or a diagnosis of Developmental and Epileptic Encephalopathy (DEE) such as Dravet syndrome or Lennox-Gastaut syndrome or other DEE.
- Subjects with Absence must experience at least 4 episodes of 3-4/second SWD lasting at least 3 seconds each in a 24 hour EEG during the baseline period. Those with DEE must have a typical EEG pattern for DEE on routine EEG and experience at least 4 seizures during the 4 week baseline period prior to BMB-101 administration.
- Subjects can be male or female ages 18-65 inclusive at time of baseline.
- Subject must have tried at least one anti-seizure medication at a recommended dose and duration and must be on a stable dose on their current anti-seizure medications for at least 4 weeks prior to baseline and remain stable throughout the study.
- Subjectis willing and able to be compliant with diary completion, visit schedule, and study drug accountability.
- Female subjects of childbearing potential must have a negative urine pregnancy test at baseline. Subjects of childbearing or child-fathering potential must be willing to use medically acceptable forms of birth control, which includes abstinence, while in this study and for 90 days after the last dose of study drug.
Who cannot join
- Subject has current or past history of cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, pulmonary hypertension, myocardial infarction or stroke, or clinically significant structural cardiac abnormality.
- Subject has moderate or severe hepatic impairment. Asymptomatic subjects with mild hepatic impairment (elevated liver enzymes < 3x upper limit of normal (ULN) and/or elevated bilirubin <2x ULN) may be entered into the study after review and approval by the Medical Monitor in conjunction with the sponsor, in consideration of comorbidities and concomitant medications.
- Subject has severe renal impairment (estimated glomerular filtration rate <30mL/min/1.73m2)
- Clinically significant ECG abnormality such as QTcF >450 msec (males) or >470 msec (females)
- Subject is receiving concomitant therapy with: fenfluramine, lorcaserin, monoamine-oxidase inhibitors, SSRIs, SNRIs, tricyclic antidepressants or other serotonergic agonists or antagonists (antipsychotics).
- Subject is currently receiving an investigational medicinal product.
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- Subject has participated in another clinical trial within the past 30 days (calculated from that study's last scheduled visit). Participation in non-treatment trials will be reviewed by the medical monitor.
- Subject has a history of drug or alcohol abuse within the last 12 months or a positive urine drug screen (with the exception of cannabinoids).
- A current C-SSRS score of 4 or 5 at baseline or history of suicide attempt at any time during the past year
- Subject has a clinically significant condition or has had clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to the Baseline Visit, other than epilepsy, that would negatively impact study participation, collection of study data, or pose a risk to the subject.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Australia5 sites, 5 recruiting
- Recruiting
St Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065
Wendyl D'Souza, +61 3 9288 3069, wendyl.dsouza@svhm.org.au
- Recruiting
Austin Health
Heidelberg, Victoria, 3084
Ingrid Scheffer, +61 3 9035 7116, i.scheffer@unimelb.edu.au
- Recruiting
Royal Brisbane and Womans Hospital
Herston, Queensland, 4029
David Reutens, +61 7 3646 2523, d.reutens@uq.edu.au
- Recruiting
Alfred Health
Melbourne, Victoria, 3004
Terrence O'Brien, MD, +61 3 9903 0855, te.obrien@alfred.org.au
- Recruiting
The Prince of Wales Hospital
Randwick, New South Wales, 2031
Christian Zentner, +612 9382 2437, Christian.Zentner@health.nsw.gov.au
About this study
Official title: An Open-Label Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of BMB-101 in Adults With Either Classic Absence Epilepsy (With or Without Eyelid Myoclonia (EEM; Jeavons Syndrome), OR Developmental Epileptic Encephalopathy (DEE).
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.
- Being tested
- BMB-101
- Medical subject headings
- Epilepsy, Absence, Epilepsies, Myoclonic, Lennox Gastaut Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMB-101Drug
BMB-101 liquid administered orally twice a day for 3 months
| Study group | Role | What they receive |
|---|---|---|
| BMB-101 | Experimental | BMB-101 10 mg/ml liquid Receives: Drug: BMB-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in seizure frequency in DEE subjects
Seizure diary
Measured: 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
Measured: 6 weeks
Secondary outcomes (1)
Change from baseline in quality of life
Quality of Life in Epilepsy (QOLIE-31) for adults
Measured: 6-10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start5 Dec 2024
- Primary completion15 Sep 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Absence EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bright Minds Biosciences Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Terence O'Brien, MD, Principal investigator, The Alfred
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401538
- Sponsor's protocol ID
- BMB-101-103
- Status last verified
- Aug 2025
- First submitted
- 2 May 2024
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No