A Study of a Drug to be Used in Addition With Another Drug to Treat Adults With Uncontrolled Partial-onset Seizures

PHASE4CompletedINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

July 7, 2017

Primary Completion Date

June 6, 2019

Study Completion Date

June 6, 2019

Conditions
Epilepsy With Partial On-set Seizures
Interventions
DRUG

Eslicarbazepine acetate

eslicarbazepine acetate tablets, taken once daily. Subjects begin 2-week Titration Phase starting on Day 1 (Week 1), by initiating treatment with ESL 400 mg/day. Subjects titrate to minimum dose of 800 mg/day for the 24-week Maintenance Phase beginning at Week 3. In the Maintenance Phase, subjects may titrate in weekly increments of 400 mg/day as medically indicated at the discretion of Investigator up to a maximum dose of 1200 mg/day (Canadian sites) or 1600 mg/day (US sites)

DRUG

Eslicarbazepine Acetate

eslicarbazepine acetate acetate tablets, taken once daily. Subjects begin 2-week Titration Phase starting on Day 1 (Week 1), by initiating treatment with ESL 400 mg/day. Subjects titrate to minimum dose of 800 mg/day for the 24-week Maintenance Phase beginning at Week 3. In the Maintenance Phase, subjects may titrate in weekly increments of 400 mg/day as medically indicated at the discretion of Investigator up to a maximum dose of 1200 mg/day (Canadian sites) or 1600 mg/day (US sites)

Trial Locations (55)

11501

NYU Winthrop Hospital, Clinical Trials Center, Mineola

15212

Alleghany General Hospital (Allegheny Neurological Association), Pittsburgh

17033

Penn State Hershey Medical Center, Hershey

19107

Drexel University, Philadelphia

19140

Temple University Lewis Katz School of Medicine, Philadelphia

20037

George Washington Medical Faculty Associates, Washington D.C.

20603

Balijeet Shethi, MD, Waldorf

20817

Mid-Atlantic Epilepsy and Sleep Center, Bethesda

27157

Wake Forest Baptist Health Sciences, Department of Neurology, Winston-Salem

27514

UNC Inverstigal Drug Services, Chapel Hill

28204

The Neurological Institute, PA, Charlotte

30042

Georgia Neurology and Sleep Medicine Associates, Suwanee

32308

Tallahassee Neurological Clinic, Tallahassee

32751

Neurology Associates PA, Maitland

32806

Neurological Services of Orlando, PA, Orlando

32819

Pedicatric Neurology, PA, Orlando

32960

Vero Beach Neurology And Reasearch Institue/The MS Center of Vero Beach, Vero Beach

33021

Infinity Clinical Research, LLC, Hollywood

33176

The Neurology Research Group, LLC, Miami

33408

Laszlo J. Mate, MD, PA, North Palm Beach

33486

Boca Raton Regional Hospital, Marcus Neuroscience Institute, Boca Raton

33606

University of South Florida, Tampa

33952

Medsol Clinical Research Center, Port Charlotte

36604

University of South Alabaa Neurology Department, Mobile

37232

Vanderbilt Epilepsy Clinic, Nashville

40513

Associates in Neurology, PSC, Lexington

40536

University of Kentucky Hospital, Chandler Medical Center, Lexington

45219

University of Cincinnati Medical Center, Cincinnati

48201

Wayne State University/Detroit Medical Center, Detroit

53715

SSM Health Dean Medical Group, Madison

55102

Minnesota Epilepsy Group, PA, Saint Paul

55422

Minneapolis Clinic of Neurology, Golden Valley

60611

Northwestern Medical Group, Deparment of Neurology, Chicago

60612

Rush University Medical Center, Chicago

66160

University of Kansas Medical Center, Kansas City

70121

Ochsner Clinic Foundation, New Orleans

73112

Sooner Clinical Research, Oklahoma City

75390

Aston Ambulatory Care Center, Dallas

78229

University of Texas Health Science Center at San Antonio Medical Arts and Research Center, San Antonio

78758

Austin Epilepsy Care Center, Austin

80113

Blue Sky Neurology, a Division of Carepoint PC, Englewood

83702

Conslutants in Epilepsy & Neurology, PLLC, Boise

85006

Banner University Medical Center Phoenix=Neuroscience Institute, Phoenix

90242

Rancho Research Institute, Inc., Downey

92037

Altman Clinical and Translational Research Institute, La Jolla

92868

University of California-Irvine, Orange

93710

Neuro-Pain Medical Center, Fresno

96817

Hawaii Pacific Neuroscience, Honolulu

97504

Providence Medical Group-Medford Neurology, Medford

06030

University of Connecticut School of Mwdicine -UCONN Health, Farmington

03756

Dartmouth-Hitchcock Medical Center, Lebanon

08820

JFK Neuroscience Institute, JFK Medical Center, Edison

08043

Clinical Research Center of NJ (CRCNJ), Voorhees Township

N6A 5A5

Londo Health Sciences Centre, University Hospital, London

J4V 2J2

Clinique D'Épilepsie Neuro Rive-Sud, Greenfield Park

All Listed Sponsors
lead

Sumitomo Pharma America, Inc.

INDUSTRY

NCT03116828 - A Study of a Drug to be Used in Addition With Another Drug to Treat Adults With Uncontrolled Partial-onset Seizures | Biotech Hunter | Biotech Hunter