Study to Assess the Safety and Tolerability of Intravenous Carbamazepine in Adults With Epilepsy

PHASE3CompletedINTERVENTIONAL
Enrollment

108

Participants

Timeline

Start Date

June 30, 2010

Primary Completion Date

January 31, 2013

Study Completion Date

January 31, 2013

Conditions
Epilepsy
Interventions
DRUG

Intravenous Carbamazepine (IV CBZ)

10 mg/mL of IV CBZ dissolved in 250 mg/mL of Captisol® (sulfobutylether-beta-cyclodextrin) dosed at 70% of the patient's daily maintenance dose of oral CBZ administered after suitable dilution with D5W by IV infusion every 6 hours.

Trial Locations (29)

10016

Langone Medical Center NYU Comprehensive Epilepsy Center, New York

10032

Columbia University Medical Center: Dept of Neurology, New York

10467

Montefiore Medicical Center, The Bronx

13210

SUNY Upstate Medical University, Syracuse

14642

University of Rochester, Rochester

19140

Temple University Health systems, Philadelphia

20815

Mid-Atlantic Epilepsy and Sleep Center, Bethesda

22903

University of Virginia, Charlottesville

27157

Wake Forest University Health Sciences, Winston-Salem

29425

Medical University of South Carolina, Charleston

33606

University of South Florida, Tampa

44195

Cleveland Clinic, Cleveland

55114

University of Minnesota & Prism Research, Saint Paul

60190

Central DuPage Hospital, Winfield

60612

University of Illinois at Chicago, Chicago

62702

Southern illinois University School of Medicine, Springfield

63017

The Comprehensive Epilepsy Care Center for Children and Adults, Chesterfield

67214

Via Christi Epilepsy Center, Wichita

70114

Louisiana Research Associates, New Orleans

70115

Ochsner Clinic Foundation, New Orleans

70363

Leonard J. Chabert Medical Center, Houma

72205

Clinical Trials Incorporated, Little Rock

75230

Neurological Clinic of Texas, P.A., Dallas

76508

Scott & White Memorial Hospital, Temple

80204

Denver Health and Hospital Authority, Denver

85054

Mayo Clinic Arizona, Phoenix

90502

Collaborative Neuroscience Network, Inc., Torrance

02215

Beth Israel Deaconess Medical Center, Boston

23298-0599

VCU Medical Center, Richmond

All Listed Sponsors
collaborator

Ligand Pharmaceuticals

INDUSTRY

collaborator

ICON Clinical Research

INDUSTRY

collaborator

Quintiles, Inc.

INDUSTRY

lead

Lundbeck LLC

INDUSTRY