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New treatment option for Absence Epilepsy
Official title BMB-101 in Absence Epilepsy and DEE
ClinicalTrials.gov ID: NCT06401538
What this study is testing
What is BMB-101?
BMB-101 is an investigational medicine, given as a twice-daily pill taken by mouth, being studied as a potential treatment for absence epilepsy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- people must have a diagnosis of Absence Epilepsy with or without eyelid myoclonia (Jeavons Syndrome) or a diagnosis of Developmental and Epileptic...
- people 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...
- people 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...
- Subjectis willing and able to be compliant with diary completion, visit schedule, and study drug accountability.
You likely can't join if
- Subject has current or past history of cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, pulmonary hypertension, myocardial...
- Subject has moderate or severe hepatic impairment. Asymptomatic people with mild hepatic impairment (elevated liver enzymes \< 3x upper limit of...
- 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...
- Subject is currently receiving an investigational medicinal product.
See the full eligibility criteria
- people 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...
- people 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...
- people 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...
- Subjectis willing and able to be compliant with diary completion, visit schedule, and study drug accountability.
- Female people of childbearing potential must have a negative urine pregnancy test at baseline. people of childbearing or child-fathering potential must be willing to use medically acceptable forms of birth control...
- 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...
- Subject has moderate or severe hepatic impairment. Asymptomatic people with mild hepatic impairment (elevated liver enzymes \< 3x upper limit of normal (ULN) and/or elevated bilirubin \<2x ULN) may be entered into the...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Randwick, New South Wales, Australia
- Herston, Queensland, Australia
- Fitzroy, Victoria, Australia
- Heidelberg, Victoria, Australia
- Melbourne, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Randwick, New South Wales, Australia; Herston, Queensland, Australia; Fitzroy, Victoria, Australia; Heidelberg, Victoria, Australia; Melbourne, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.