Nonconvulsive Seizures Clinical Trial
Official title:
Utility of Intravenous Lacosamide Compared With Fosphenytoin in the Treatment of Patients With Frequent Nonconvulsive Seizures
This a phase 2 study comparing the efficacy of intravenous (IV) lacosamide (LCM) with IV fosphenytoin (fPHT) in controlling frequent nonconvulsive seizures (NCSs), the Adverse Events profile of LCM compared with fPHT when used to treat frequent NCSs, and length of stay in an intensive care unit for subjects treated with LCM versus subjects treated with fPHT. The trial will include a preacute-treatment period, an acute-treatment period, a postacute-treatment period, and a long-term follow-up period.
Exploratory, prospective, multicenter, open-label, randomized study, in which the physicians
who are interpreting cEEGs for treatment purposes and the central reviewers who are providing
final cEEG interpretation for study purposes are all blinded to treatment.
Initial LCM/maintenance doses: Subjects will receive a 400‑mg IV initial bolus over 30
minutes, followed by a 2-hour post-dose observation-only period. If a breakthrough seizure
occurs in the 6 hours following the 2‑hour post-dose observation-only period, the subject
will receive a 200‑mg rebolus over 30 minutes. Regardless of whether a rebolus was
administered, a maintenance dose of LCM will be started 12 hours after the initial bolus, and
it will continue every 12 hours throughout the acute-treatment period. The daily maintenance
dose will be equivalent to the total IV bolus per day (400 mg if no rebolus was administered
or 600 mg if a rebolus was administered), divided into 2 doses. After completion of the
acute-treatment period, daily maintenance with an AED will be at the discretion of the
treating physician.
Initial fPHT/maintenance doses: Subjects will receive a 20‑mg PE/kg IV initial bolus at a
rate no greater than 75 mg PE/minute, followed by a 2‑hour post-dose observation-only period.
If a breakthrough seizure occurs in the 6 hours following the 2‑hour post-dose
observation-only period, the subject will receive a 5‑mg PE/kg IV rebolus at a rate no
greater than 75 mg PE/minute. Regardless of whether a rebolus was administered, a maintenance
dose of fPHT will be started 12 hours after the initial bolus, and it will continue every 12
hours throughout the acute-treatment period. The daily maintenance dose will be 5 mg PE/kg,
divided into 2 doses. After completion of the acute-treatment period, daily maintenance with
an AED will be at the discretion of the treating physician.
Crossover/maintenance doses: If a subject does not receive a rebolus but has a seizure within
24 hours following the 2-hour post-initial-dose observation-only period, he or she will
"cross over" and begin receiving the other drug, ie, the one not originally administered. If
a subject does receive a rebolus and has another seizure within 24 hours following the 2-hour
post-rebolus observation-only period, he or she will also cross over to the other drug. If
crossover occurs, the subject will "start over" with the second drug, going through the same
observation-only period and rebolusing, if necessary. If a subject crosses over and starts
receiving the second drug, in addition to receiving every-12‑hours maintenance doses of the
drug originally administered, the subject will also receive maintenance doses of the second
drug every 12 hours, beginning 12 hours after the first dose of the second drug.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02082873 -
Nonconvulsive Seizure Identification on Quantitative EEG by Neuro ICU Nurses
|