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Bumetanide · 1 trial · 1 indication
The investigators will determine the dose exposure, half-life, volume of distribution and clearance of bumetanide in newborns with refractory seizures. The investigators will determine if there is a significant effect of hepatic dysfunction or hypothermia on bumetanide pharmacokinetics. For evaluation of safety, the rate of adverse events will be compared between treatment and control groups.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Standard phenobarbital combined with either 0.1 mg/kg, 0.2 mg/kg, or 0.3 mg/kg of bumetanide as determined by the status of the dose escalation design. |
| 2 | PLACEBO_COMPARATOR | Standard phenobarbital therapy combined with normal saline as placebo for bumetanide |
| Name | Type | Description |
|---|---|---|
| Bumetanide | DRUG | Bumetanide either 0.1 mg/kg, 0.2 mg/kg or 0.3 mg/kg IV administered together with standard phenobarbital therapy |
| Normal Saline as Placebo | DRUG | Normal Saline as placebo for bumetanide either 0.1 mg/kg, 0.2 mg/kg or 0.3 mg/kg IV administered together with standard phenobarbital therapy |
Inclusion Criteria: * newborns with a post-conceptional age of 33-44 weeks * condition with risk for seizure: * asphyxia * intracranial hemorrhage * suspected or confirmed stroke * CNS infection * genetic syndrome * focal or diffuse brain malformation * idiopathic or presumed genetic...
Bumetanide is an investigational small molecule being studied for the treatment of seizures in newborns. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being developed by Catalyst Pharmaceuticals, Inc. (CPRX).
Bumetanide is a small molecule being studied for its potential to treat seizures. The specific molecular target of Bumetanide has not been disclosed in the available information. It is currently in Phase 1 clinical trials for newborn seizures.
Bumetanide is being developed by Catalyst Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CPRX. The company is conducting clinical research on Bumetanide for the treatment of seizures in newborns.
Bumetanide is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The drug is being studied for the treatment of seizures in newborns, and a Phase 1 clinical trial has been completed.
Bumetanide has been studied in a Phase 1 clinical trial with the identifier NCT00830531, titled 'Pilot Study of Bumetanide for Newborn Seizures.' This trial was completed and enrolled 43 participants in the United States. The study was randomized, double-blind, and placebo-controlled.
Bumetanide is an investigational drug being developed by Catalyst Pharmaceuticals, Inc. for the treatment of seizures. No alternative names for Bumetanide have been disclosed in the available information. It is currently in Phase 1 clinical development.