RecruitingPhase 2NCT06401538

BMB-101 in Absence Epilepsy and DEE

An Open-Label Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of BMB-101 in Adults With Either Classic Absence Epilepsy (With or Without Eyelid Myoclonia (EEM; Jeavons Syndrome), OR Developmental Epileptic Encephalopathy (DEE).


Sponsor

Bright Minds Biosciences Pty Ltd

Enrollment

20 participants

Start Date

Dec 5, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called BMB-101 for people with dravet syndrome, jeavons syndrome, and other related conditions. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBMB-101

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


Locations(5)

The Prince of Wales Hospital

Randwick, New South Wales, Australia

Royal Brisbane and Womans Hospital

Herston, Queensland, Australia

St Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

Austin Health

Heidelberg, Victoria, Australia

Alfred Health

Melbourne, Victoria, Australia

View Full Details on ClinicalTrials.gov

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NCT06401538


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