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

Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nonconvulsive Seizures

Intervention: Lacosamide - 'Crossover' (Drug); Fosphenytoin - 'crossover' (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Aatif Husain

Official(s) and/or principal investigator(s):
Aatif Husain, MD, Principal Investigator, Affiliation: Duke Clinical Research Institute

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.

Clinical Details

Official title: Utility of Intravenous Lacosamide Compared With Fosphenytoin in the Treatment of Patients With Frequent Nonconvulsive Seizures

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Percentage of subjects who experience no NCSs for 24 hours following treatment with LCM vs. fPHT, as measured by continuous electroencephalography (cEEG) monitoring.

Secondary outcome:

Percentage of subjects who require a rebolus of the initial antiepileptic drug (AED) to control NCSs in the LCM vs fPHT arms.

Percentage of subjects who require a second AED to control NCSs.

Percent change in seizure time (defined as the number of minutes of electrographic seizure (ESz) activity per hour) before treatment and at the end of the first treatment arm.

Percent change in seizure time (defined as the number of minutes of ESz activity per hour) before treatment and at the end of the second treatment arm.

Time from bolus to time of the end of the last seizure for both first (initial bolus/rebolus)and second (crossover bolus/rebolus) treatment arms.

Frequency of predefined adverse events (AEs) in the LCM vs fPHT arms.

Percentage of subjects in whom study drug is withdrawn early

Days in the intensive care unit/hospital from start of treatment in the LCM vs fPHT arms.

Functional status as measured by the Functional Disability Scale at Day 7 to 9 postrandomization and Day 30 post-randomization in the LCM vs fPHT arms.

Percentage of all subjects who have had a seizure, are on AED therapy, and are alive/dead at the 6-, 12-, and 24-month post-randomization follow-ups.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Huntington Memorial Hospital, Pasadena, California 91109, United States

Yale University School of Medicine, New Haven, Connecticut 06520, United States

Emory University School of Medicine, Atlanta, Georgia 30307, United States

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States

Brigham and Woman's Hospital, Boston, Massachusetts 02215, United States

Massachusetts General Hospital, Boston, Massachusetts 02214, United States

Mission Hospital, Asheville, North Carolina 28801, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

Medical University of South Carolina, Charleston, South Carolina 29425, United States

Vanderbilt University Medical Center, Nashville, Tennessee 37232, United States

University of Texas Southwestern Medical Center Dallas, Dallas, Texas 75390-8589, United States

Additional Information

Starting date: May 2012
Last updated: January 22, 2015

Page last updated: August 23, 2015

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