Intravenous Lacosamide Compared With Fosphenytoin in the Treatment of Patients With Frequent Nonconvulsive Seizures

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aatif Husain
• Collaborator: UCB Pharma
• Treatments: Fosphenytoin; Lacosamide; Phenytoin

Criteria

Inclusion Criteria:

1. Have the capacity to understand and sign an institutional review board (IRB)-approved informed consent form (ICF) or have a legally authorized representative (LAR) available to sign on behalf of the subject.

2. Are undergoing cEEG monitoring in the neurologic intensive care unit (NICU) or other closely monitored environment.

3. Are experiencing NCSs according to the following criteria:

• At least 1 ESz lasting at least 10 seconds, with or without clinical correlates, occurring within the last 6 hours of cEEG monitoring.

• If a new AED has been started, ESzs must have occurred per the preceding bullet point at least 2 hours after starting that AED.

• If individual ESzs are not well defined, ESz time is at least 10 seconds and less than 30 minutes per hour of cEEG recording.

4. Are being considered for treatment with an IV AED.

5. Are at least 18 years old.

Exclusion Criteria:

1. Treatment with PHT, fPHT, or LCM in the last 7 days.

2. Contraindication for the use of fPHT or LCM.

3. Ongoing generalized convulsive status epilepticus (SE) (more than 2 generalized tonic-clonic seizures within 30 minutes without recovery to baseline or 1 seizure lasting longer than 10 minutes).

4. Episodes of SE, defined as at least 30 minutes of ESz activity in 1 hour, in the last 6 hours.

5. Encephalopathic event secondary to acute anoxic/hypoxic event.

6. Undergoing therapeutic hypothermia protocol.

7. Continuous EEG monitoring showing only periodic discharges or rhythmic delta activity without clear ESzs (for definitions of periodic discharges, rhythmic delta activity, and ESzs, see the Manual of Operations).

8. Electroencephalographic seizures consistent with typical absence seizures.

9. Evaluation for spell characterization or surgical treatment for epilepsy.

10. Pregnancy.