Phase
Condition
Epilepsy
Seizure Disorders
Seizure Disorders (Pediatric)
Treatment
BMB-101
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 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.
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 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.
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 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:
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.
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.
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 otherserotonergic 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-treatmenttrials will be reviewed by the medical monitor.
Subject has a history of drug or alcohol abuse within the last 12 months or apositive 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 anytime during the past year
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
Connect with a study center
Alfred Health
Melbourne, Victoria 3004
AustraliaActive - Recruiting
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