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Lorazepam · 1 trial · 1 indication
Participants with clinical benefit were defined as participants whose initial seizure stopped within 10 minutes after initial dose (Dose 1) and who continued seizure-free for at least 30 minutes after the completion of initial dose (Dose 1).
| Arm | Type | Description |
|---|---|---|
| Lorazepam | EXPERIMENTAL | Lorazepam intravenous formulation |
| Name | Type | Description |
|---|---|---|
| Lorazepam | DRUG | intravenous administration. Dosage for adult subjects (16 years aged and over): 4 mg Dosage for pediatric subjects (3 months to \< 16 years): 0.05 mg/kg (but not exceeding 4 mg) Frequency: Intravenous administration of lorazepam. Subjects whose seizure does not stop or recurs within 10 minutes after the initial dose may receive the same amount of lorazepam injection no earlier than 10 minutes following the initial dose. Also, subjects whose seizure stops within 10 minutes after the initial dose, but recurs thereafter (within 12 hours) may receive the same amount of lorazepam injection; a total of 2 doses will be permitted in this study. |
Inclusion Criteria: * Subjects with status epilepticus or repetitive status epilepticus / cluster seizure who have seizures that can be evaluated by investigator's visual observations based on motor symptoms or who have seizures that can be evaluated by EEG. * Subjects with status epilepticus accom...
Lorazepam is being studied for the treatment of status epilepticus or repetitive status epilepticus. Status epilepticus is a medical emergency in which seizures do not stop on their own or occur in rapid succession. The clinical development program for this indication has been conducted in Japan.
Lorazepam is a positive allosteric modulator that targets GABA-A receptor subunits, specifically GABRA1, GABRB2, GABRG2, GABRB3, GABRA4, and GABRG3. By binding to these sites, it enhances the inhibitory effects of the neurotransmitter GABA, which helps suppress excessive neuronal activity such as that seen in status epilepticus.
Lorazepam is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the company associated with the clinical development program for lorazepam in status epilepticus.
Lorazepam is in Phase 3 clinical development for status epilepticus. The Phase 3 trial has been completed, and no active trials are currently listed. It is an investigational use in this program and is not described as approved for this indication.
Lorazepam has been evaluated in one completed Phase 3 trial, NCT02239380, titled "Lorazepam for the Treatment of Status Epilepticus or Repetitive Status Epilepticus in Japan." The trial enrolled 26 participants in Japan, including patients as young as 3 months, and was uncontrolled and not randomized.