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The designation placebo + basimglurant refers to a clinical trial regimen, specifically within the context of the Phase 2B GALENE study (NCT05059327), which utilizes a double-blind, placebo-controlled, crossover design. In this study, participants with uncontrolled seizures associated with Tuberous Sclerosis Complex (TSC) receive both basimglurant and a matching placebo in alternating treatment periods. Basimglurant (also known as NOE-101) is an investigational small molecule that acts as a potent and selective negative allosteric modulator (NAM) of the metabotropic glutamate receptor 5 (mGluR5). By selectively inhibiting mGluR5, basimglurant modulates glutamatergic signaling, which is often overactive in neurological disorders, thereby reducing neuronal excitability and seizure frequency. The drug is being developed by Noema Pharma for orphan neurological conditions, including TSC-related epilepsy, trigeminal neuralgia, and persistent developmental stuttering.
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