BMB-101 in Absence Epilepsy and DEE

Last updated: December 12, 2024
Sponsor: Bright Minds Biosciences Pty Ltd
Overall Status: Active - Recruiting

Phase

2

Condition

Epilepsy

Seizure Disorders

Seizure Disorders (Pediatric)

Treatment

BMB-101

Clinical Study ID

NCT06401538
BMB-101-103
  • Ages 18-65
  • All Genders

Study 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. 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.

Eligibility Criteria

Inclusion

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 lastingat least 3 seconds each in a 24 hour EEG during the baseline period. Those with DEEmust have a typical EEG pattern for DEE on routine EEG and experience at least 4seizures 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 doseand duration and must be on a stable dose on their current anti-seizure medicationsfor 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 testat baseline. Subjects of childbearing or child-fathering potential must be willingto use medically acceptable forms of birth control, which includes abstinence, whilein this study and for 90 days after the last dose of study drug.

Exclusion

Exclusion Criteria:

  1. Subject has current or past history of cardiovascular or cerebrovascular disease,such as cardiac valvulopathy, pulmonary hypertension, myocardial infarction orstroke, or clinically significant structural cardiac abnormality.

  2. Subject has moderate or severe hepatic impairment. Asymptomatic subjects with mildhepatic impairment (elevated liver enzymes < 3x upper limit of normal (ULN) and/orelevated bilirubin <2x ULN) may be entered into the study after review and approvalby the Medical Monitor in conjunction with the sponsor, in consideration ofcomorbidities 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 otherserotonergic 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-treatmenttrials will be reviewed by the medical monitor.

  8. Subject has a history of drug or alcohol abuse within the last 12 months or apositive 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 anytime during the past year

  10. Subject has a clinically significant condition or has had clinically relevantsymptoms or a clinically significant illness in the 4 weeks prior to the BaselineVisit, other than epilepsy, that would negatively impact study participation,collection of study data, or pose a risk to the subject.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: BMB-101
Phase: 2
Study Start date:
December 05, 2024
Estimated Completion Date:
October 15, 2025

Connect with a study center

  • Alfred Health

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

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