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

Completed · Phase 2

Conditions studied: Nonconvulsive Seizures

In brief

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.

Key facts

Study ID

NCT01458522

Run by

Aatif Husain

People needed

74

Starts

2012-05-01

Expected to finish

2015-07-01

Last updated by the study team

2018-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Are undergoing cEEG monitoring in the neurologic intensive care unit (NICU) or other closely monitored environment.
• 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.
• Are being considered for treatment with an IV AED.
• Are at least 18 years old.

You may not qualify if…

• Treatment with PHT, fPHT, or LCM in the last 7 days.
• Contraindication for the use of fPHT or LCM.
• 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).
• Episodes of SE, defined as at least 30 minutes of ESz activity in 1 hour, in the last 6 hours.
• Encephalopathic event secondary to acute anoxic/hypoxic event.
• Undergoing therapeutic hypothermia protocol.
• 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).
• Electroencephalographic seizures consistent with typical absence seizures.
• Evaluation for spell characterization or surgical treatment for epilepsy.
• Pregnancy.

Where it is running

• Huntington Memorial Hospital — Pasadena, California, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Brigham and Woman's Hospital — Boston, Massachusetts, United States
• Mission Hospital — Asheville, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Texas Southwestern Medical Center Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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