74
Participants
Start Date
May 31, 2012
Primary Completion Date
July 31, 2014
Study Completion Date
July 31, 2015
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."
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."
Duke University Medical Center, Durham
Mission Hospital, Asheville
Medical University of South Carolina, Charleston
Emory University School of Medicine, Atlanta
Vanderbilt University Medical Center, Nashville
Huntington Memorial Hospital, Pasadena
Yale University School of Medicine, New Haven
Massachusetts General Hospital, Boston
Beth Israel Deaconess Medical Center, Boston
Brigham and Woman's Hospital, Boston
University of Texas Southwestern Medical Center Dallas, Dallas
Collaborators (1)
UCB Pharma
INDUSTRY
Aatif Husain
OTHER