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BMB-101 · 2 trials · 5 indications
The Hyperphagia Questionnaire for Clinical Trials consists of 9 items; each rated on a scale from 0 (no symptoms) to 4 (severe symptoms). The total score ranges from 0 to 36, with higher scores indicating worse hyperphagia symptoms. A score of approximately 13 is associated with moderate to severe hyperphagia, and a score of 22 or greater is associated with severe hyperphagia.
Seizure diary
24 hour EEG
| Arm | Type | Description |
|---|---|---|
| BMB-101 | EXPERIMENTAL | Participants receive BMB-101 (10mg/mL liquid) orally |
| Placebo | PLACEBO_COMPARATOR | Participants receiving matched placebo orally |
| Name | Type | Description |
|---|---|---|
| BMB-101 | DRUG | Participants will receive weekly ascending oral doses of BMB-101(10 mg/mL) twice daily (BID) for 16 weeks. Doses will be based on weight (kg) and will initially start at 1.67 mg/kg. Doses may be titrated in 0.33 mg/kg increments based on tolerability up to a maximum dose of 2.0 mg/kg. |
| Placebo | DRUG | Matched Placebo |
Inclusion Criteria: * Participant must be aged 18-65 years (both inclusive). * Genetically confirmed diagnosis of Prader Willi Syndrome via standard DNA testing or other commonly approved methods. * Willing and able to provide voluntary written informed consent, or have a Legally Authorized Represe...
BMB-101 is an investigational small molecule being developed by Bright Minds Biosciences Inc. for neurological conditions. It is in Phase 2 clinical development for absence epilepsy and Prader-Willi syndrome. BMB-101 has not been approved by the FDA and remains under clinical study.
BMB-101 is being studied for the treatment of absence epilepsy and Prader-Willi syndrome. Clinical trials are also evaluating it in related epilepsy conditions including Jeavons syndrome, Dravet syndrome, and Lennox-Gastaut syndrome. It is investigational and not approved for any indication.
BMB-101 targets the 5-HT2C receptor, a serotonin receptor. By acting on this receptor, the small molecule is designed to modulate serotonergic signaling relevant to neurological conditions such as absence epilepsy and Prader-Willi syndrome. It is currently in Phase 2 development.
BMB-101 is being developed by Bright Minds Biosciences Inc., which trades under the ticker DRUG. The company is advancing the small molecule through Phase 2 clinical trials in neurology indications including absence epilepsy and Prader-Willi syndrome.
BMB-101 is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. The Phase 2 program includes studies in absence epilepsy and related epilepsy syndromes as well as Prader-Willi syndrome.
BMB-101 is being evaluated in two Phase 2 trials. NCT06401538 is recruiting participants with absence epilepsy and related developmental and epileptic encephalopathies in Australia. NCT07266324 is a not-yet-recruiting Phase 2 study in adults with Prader-Willi syndrome, also in Australia.