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Also known as Huperzine A ER
BIS-001ER · 1 trial · 1 indication
Reduction in average daily seizure count between baseline (pre-treatment) and evaluation (on treatment) video EEG monitoring periods.
| Arm | Type | Description |
|---|---|---|
| BIS-001ER | EXPERIMENTAL | Dose administration for each participant will begin at 0.25mg b.i.d. escalating sequentially every 4 days to a maximum tolerated dose or target dose of 1.75mg b.i.d. Upon reaching the target dose or maximum tolerated dose, participants will maintain that dose for the balance of the 1 month out-patient titration period, after which they will begin a 96-hour in-patient video EEG monitoring treatment period. |
| Name | Type | Description |
|---|---|---|
| BIS-001ER | DRUG | BIS-001 ER is an extended release formulation of the nutritional supplement Huperzine A. |
Inclusion Criteria: * Speak English with sufficient proficiency to read and comprehend the Informed Consent document, and to communicate with study staff. * Be able to consent to participate by signing the Informed Consent document after a full explanation of the nature and purpose of this study. *...
BIS-001ER is an investigational small molecule being developed for the treatment of Focal Impaired Awareness Seizures in adults. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being studied in a clinical trial to evaluate its safety and tolerability in this patient population.
BIS-001ER targets acetylcholinesterase (ACHE), an enzyme that breaks down the neurotransmitter acetylcholine. By inhibiting ACHE, the drug may increase acetylcholine levels in the brain, which could modulate neuronal activity relevant to seizure control. This mechanism is being investigated for its potential benefit in Focal Impaired Awareness Seizures.
BIS-001ER is being developed by Supernus Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SUPN. The company is conducting clinical research on this drug candidate for the treatment of Focal Impaired Awareness Seizures.
BIS-001ER is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is designed to assess the drug's safety, tolerability, and pharmacokinetics in adult patients with Focal Impaired Awareness Seizures.
BIS-001ER is being studied in a Phase 1 clinical trial registered as NCT03474770, titled "BIS-001-ER for the Treatment of Adult Focal Impaired Awareness Seizures." This active, non-recruiting study is enrolling 16 participants aged 18 years and older in Australia. The trial is uncontrolled and not blinded, focusing on safety and tolerability.
BIS-001ER is a specific extended-release formulation of the drug candidate BIS-001. The "ER" designation indicates an extended-release version designed for once-daily dosing. While BIS-001 refers to the active compound, BIS-001ER is the formulation being evaluated in clinical trials for Focal Impaired Awareness Seizures.