Health TrialsbyHealthPanel

BMB-101 in Absence Epilepsy and DEE

ConditionsAbsence EpilepsyJeavons SyndromeDravet SyndromeLennox Gastaut Syndrome
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBright Minds Biosciences Pty Ltd

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • BMB-101

    Drug

    BMB-101 liquid administered orally twice a day for 3 months

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: BMB-101Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in seizure frequency in DEE subjects

Seizure diary

Time frame
10 weeks
2

Change from baseline in the number of generalized spike-wave discharges (GSWD) on the 24 hr EEG in Absence subjects.

24 hour EEG

Time frame
6 weeks

Secondary outcomes

1

Change from baseline in quality of life

Quality of Life in Epilepsy (QOLIE-31) for adults

Time frame
6-10 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bright Minds Biosciences Pty Ltd

Lead sponsor

Source ClinicalTrials.gov
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