Clinical trials

2

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Condition / disease
Location
Status: Not yet recruiting

A 2-Part Study to Assess Efficacy, Safety and Tolerability of BMB-101 for the Treatment of Patients With Prader-Willi Syndrome.

The goal of this clinical trial is to evaluate the safety and effects of a new drug called BMB-101 in people with Prader-Willi Syndrome (PWS). This study is designed as a multi-centre, double-blind, randomized, placebo controlled 2-part study with a blinded main phase followed up an open label extension phase.

Participants needed: 16
Trial details
Phase: Phase 2Age: 18-65Biological sex: AllType: InterventionalSponsor: Bright Minds Biosciences Pty LtdUpdated: Dec 5, 2025Locations: 2
Eligibility criteria

Participant must be aged 18-65 years (both inclusive). [+7]

Participant has used metabolic agents known to affect appetite within 3 months o... [+12]

Status: Recruiting

BMB-101 in Absence Epilepsy and DEE

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.

Participants needed: 20
Trial details
Phase: Phase 2Age: 18-65Biological sex: AllType: InterventionalSponsor: Bright Minds Biosciences Pty LtdUpdated: Aug 12, 2025Locations: 5
Eligibility criteria

Subjects must have a diagnosis of Absence Epilepsy with or without eyelid myoclo... [+5]

Subject has current or past history of cardiovascular or cerebrovascular disease... [+9]