BMB-101 in Absence Epilepsy and DEE

Launched by BRIGHT MINDS BIOSCIENCES PTY LTD · May 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BMB-101 to see if it can safely reduce the number of seizures in adults with Absence Epilepsy, Jeavons Syndrome, and certain severe forms of epilepsy known as Developmental Epileptic Encephalopathies (DEE), like Dravet and Lennox-Gastaut syndromes. The trial will last up to 6 months and includes a month of screening, followed by up to 3 months of receiving BMB-101, and then a month of follow-up. Participants will have a total of 6 visits to the clinic during this time.

To be eligible for the trial, participants must be between 18 and 65 years old and have a confirmed diagnosis of Absence Epilepsy or DEE. They should have tried at least one anti-seizure medication and be stable on their current medication for at least 4 weeks before starting the trial. It’s important for participants to be committed to completing diaries and attending scheduled visits. Those interested should note that there are some health conditions that would exclude them from participating, such as significant heart or liver problems.

Gender

ALL

Eligibility criteria

• 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 \< 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.
• • 3. Subject has severe renal impairment (estimated glomerular filtration rate \<30mL/min/1.73m2)
• • 4. Clinically significant ECG abnormality such as QTcF \>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.