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

PHASE2CompletedINTERVENTIONAL
Enrollment

74

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

July 31, 2014

Study Completion Date

July 31, 2015

Conditions
Nonconvulsive Seizures
Interventions
DRUG

fPHT

"If after initial treatment with fPHT any of the following occurs, the subject will have reached the end of the first treatment arm and will cross over and begin receiving the other drug, ie, the one not originally administered: the subject subsequently has another seizure within 24 hours following the 2-hour post-rebolus observation-only period; the subject does not receive a rebolus but has a seizure within 24 hours following the 2 hour post-bolus observation-only period; the subject experiences an AE that precludes further use of the first study drug.~If crossover occurs, the subject will start over with the second drug, going through the same observation-only period, rebolusing (if necessary), and study assessments with the second drug, beginning with the Baseline assessments."

DRUG

LCM

"If after initial treatment with LCM any of the following occurs, the subject will have reached the end of the first treatment arm and will cross over and begin receiving the other drug, ie, the one not originally administered: the subject subsequently has another seizure within 24 hours following the 2-hour post-rebolus observation-only period; the subject does not receive a rebolus but has a seizure within 24 hours following the 2 hour post-bolus observation-only period; the subject experiences an AE that precludes further use of the first study drug.~If crossover occurs, the subject will start over with the second drug, going through the same observation-only period, rebolusing (if necessary), and study assessments with the second drug, beginning with the Baseline assessments."

Trial Locations (11)

27710

Duke University Medical Center, Durham

28801

Mission Hospital, Asheville

29425

Medical University of South Carolina, Charleston

30307

Emory University School of Medicine, Atlanta

37232

Vanderbilt University Medical Center, Nashville

91109

Huntington Memorial Hospital, Pasadena

06520

Yale University School of Medicine, New Haven

02214

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

Brigham and Woman's Hospital, Boston

75390-8589

University of Texas Southwestern Medical Center Dallas, Dallas

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

UCB Pharma

INDUSTRY

lead

Aatif Husain

OTHER