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BMB-101 in Absence Epilepsy and DEE

StatusRecruiting
PhasePhase 2
Started
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Record status
This record was last updated August 12, 2025 (before its estimated September 15, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Study sites: 1 to 5
    • Study completion date: Oct 15, 2025 to Nov 30, 2025
    v4
  2. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Start date changed from estimate of Sep 15, 2024 to Dec 5, 2024
    • Eligibility criteria shortened, about 21 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised
  3. Start date: Jul 15, 2024 to Sep 15, 2024v2 Show 5 more changesShow less
    • Primary endpoints: 1 to 2
    • Primary completion date: Jul 15, 2025 to Sep 15, 2025
    • Eligibility criteria expanded, about 151 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study title shortened, about 1 word
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06401538
Lead Sponsor Bright Minds Biosciences Pty Ltd
Conditions
(from sponsor)		 Absence Epilepsy, Jeavons Syndrome, Dravet Syndrome, Lennox Gastaut Syndrome
Related terms Epilepsies, Myoclonic, Epilepsy, Absence, Lennox Gastaut Syndrome
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov