Who may be eligible for the BMB-101 in Absence Epilepsy and DEE trial?

Inclusion Criteria: 1. 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. 2. 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. 3. Subjects can be male or female ages 18-65 inclusive at time of baseline. 4. 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. 5. Subjectis willing and able to be compliant with diary completion, visit schedule, and study drug accountability. 6. 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. Exclusion Criteria: 1. 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. 2. Subject has moderate or severe hepatic impairment. Asymptomatic subjects with mild hepatic impairment (elevated liver enzymes \ 450 msec (males) or \>470 msec (females) 5. Subject is receiving concomitant therapy with: fenfluramine, lorcaserin, monoamine-oxidase inhibitors, SSRIs, SNRIs, tricyclic antidepressants or other serotonergic agonists or antagonists (antipsychotics). 6. Subject is currently receiving an investigational medicinal product. 7. 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. 8. 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). 9. A current C-SSRS score of 4 or 5 at baseline or history of suicide attempt at any time during the past year 10. 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.

ClinicalTrials.gov record NCT06401538

BMB-101 in Absence Epilepsy and DEE

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Aug 22, 2026

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).

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

PhasePhase 2A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.

Age18 years old to 65 years old

SexAll

LocationAustralia

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is an open-label Phase 2 study testing BMB-101 in adults with Absence Epilepsy (with or without eyelid myoclonia/Jeavons) or developmental epileptic encephalopathies (for example Dravet or Lennox‑Gastaut). The study lasts up to 6 months: 1 month screening, up to 3 months on BMB-101 (including titration and taper/washout), and a 1 month follow-up. There are six clinic visits during the study.

What it is studying. The study is testing whether BMB-101 is safe, tolerable, and how it affects seizure frequency and EEG measures in adults with Absence Epilepsy or developmental epileptic encephalopathy (DEE). It collects seizure diaries and 24‑hour EEGs and measures quality of life.

What the researchers hope to learn. To evaluate safety and tolerability of BMB-101; to measure change from baseline in seizure frequency for DEE participants; to measure change from baseline in generalized spike‑wave discharges on 24‑hour EEG for Absence participants; and to assess change in quality of life.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug: BMB-101

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

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.

Exclusion criteria

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.
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.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

After a 1‑month screening period, participants take BMB‑101 oral liquid twice daily for up to 3 months (this includes dose titration and a taper/washout), followed by a 1‑month follow‑up; the study schedules six clinic visits. Participants keep seizure diaries and attend visits for EEG recordings (including a 24‑hour EEG for Absence subjects), ECGs and required safety tests such as pregnancy tests and other lab checks as needed. Participants must keep their anti‑seizure medications stable, complete study diaries, and follow study visit and drug‑accountability procedures.

How the study is structured. An open-label, single-group (no placebo) Phase 2 drug trial. Adults receive oral BMB-101 twice daily for up to three months. The study includes a baseline/screening period, on-drug treatment with titration and taper/washout, scheduled clinic visits (six total), seizure diaries, 24‑hour EEGs for absence epilepsy, and quality-of-life questionnaires.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The listed sites are in Australia. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on CDKL5 deficiency disorder

This trial is also listed on this site under Dravet syndrome.

Clinical trials22 trials listed for CDKL5 deficiency disorderEvery trial the registry lists for CDKL5 deficiency disorder, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in CDKL5 deficiency disorder researchLatest monthly update: September 2026. Includes: EEG background changes. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Dec 5, 2024
Primary completion: Sep 15, 2025 (estimated)
Study completion: Nov 30, 2025 (estimated)
Target enrollment: 20 participants (estimated)
Last updated on registry: Aug 12, 2025
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Bright Minds Biosciences Pty Ltd

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Rachelle Kirk-Burnnand 📞 +61 439615368 ✉ rachelle@basebio.com.au

Participating sites (5)

The Prince of Wales HospitalRecruiting
Randwick, New South Wales, 2031 · Australia
- Christian Zentner · +612 9382 2437 · Christian.Zentner@health.nsw.gov.au
Royal Brisbane and Womans HospitalRecruiting
Herston, Queensland, 4029 · Australia
- David Reutens · +61 7 3646 2523 · d.reutens@uq.edu.au
St Vincent's Hospital MelbourneRecruiting
Fitzroy, Victoria, 3065 · Australia
- Wendyl D'Souza · +61 3 9288 3069 · wendyl.dsouza@svhm.org.au
Austin HealthRecruiting
Heidelberg, Victoria, 3084 · Australia
- Ingrid Scheffer · +61 3 9035 7116 · i.scheffer@unimelb.edu.au
Alfred HealthRecruiting
Melbourne, Victoria, 3004 · Australia
- Terrence O'Brien, MD · +61 3 9903 0855 · te.obrien@alfred.org.au

Terms used on this page · explanations by MedicalUpdates.ai

open-label: No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
screening period: The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
washout: A period during which a participant stops a previous treatment before starting the study treatment, so the earlier treatment does not affect the results.
follow-up: The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
baseline: Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
stable dose: A dose that has not changed for a defined period before the study starts. Studies may require this so that background treatment is relatively stable when study measurements begin.
study drug: A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
childbearing potential: Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
upper limit of normal: The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
sponsor: The organisation or person that initiates the study and has authority over it. The sponsor may be a company, hospital, university, government agency or individual, and is not necessarily the organisation that funds the study.
concomitant medications: Other medicines a participant takes during the study. Some must be reported; some are restricted.
estimated glomerular filtration rate: A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
ECG: A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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