Clobazam in Patients With Lennox-Gastaut Syndrome

PHASE3CompletedINTERVENTIONAL
Enrollment

238

Participants

Timeline

Start Date

August 31, 2007

Primary Completion Date

December 31, 2009

Study Completion Date

April 30, 2010

Conditions
EpilepsyEpilepsy, GeneralizedSeizures
Interventions
DRUG

Clobazam Low Dose

0.25 mg/kg/day; tablets; orally; for 15-18 weeks

DRUG

Clobazam Medium Dose

0.5 mg/kg/day; tablets; orally; for 15-18 weeks

DRUG

Clobazam High Dose

1.0 mg/kg/day; tablets; orally; for 15-18 weeks

DRUG

Placebo

tablets; orally; daily for 15-18 weeks

Trial Locations (53)

2067

Strategic Health Evaluators, Chatswood

3050

Royal Melbourne Hospital Department of Neurology, Melbourne

3081

Austin & Repatriation Hospital (Austin Health) Epilepsy Research Centre, Melbourne

14450

University of Rochester Medical Center, Rochester

19104

The Children's Hospital of Philadelphia, Philadelphia

19107

Jefferson Epilepsy Center, Philadelphia

20010

Children's National Medical Center, Washington D.C.

20817

Mid-Atlantic Epilepsy and Sleep Center, Bethesda

30912

Medical College of Georgia, Augusta

32504

Child Neurology Center of NW FL, Pensacola

33470

Pediatric Neurology and Epilepsy Center, Loxahatchee Groves

33606

University of South Florida, Tampa

33609

Pediatric Epilepsy & Neurology Specialists, Tampa

35081

University of Alabama at Birmingham, Huntsville

38105

UTMG Pediatric Neurology, Memphis

45219

University Neurology, Inc., Cincinnati

55012

Minnesota Epilepsy Group, Saint Paul

60612

Rush University Medical Center, Chicago

60637

University of Chicago Medical Center, Chicago

61516

Children's Memorial Hospital, Chicago

63017

The Comprehensive Epilepsy Care Center for Children and Adults, Chesterfield

71103

LSU Health Sciences Center, Shreveport

75235

Children's Medical Center at UT Southwestern-Dallas, Dallas

76104

Cook Children's Health Care System, Fort Worth

77030

Baylor College of Medicine Pediatric Neurology, Houston

80045

The Children's Hospital, Aurora

83712

Pediatric Neurology of Idaho Children's Specialty Center, Boise

85013

St. Joseph's Hospital and Medical Center, Phoenix

85216

Phoenix Children's Hospital, Phoenix

90027

Childrens Hospital Los Angeles, Los Angeles

110002

Maulana Azad Medical College and Associated Lok Nayak Govind Ballabh Pant Hospitals and Guru Nanak Eye centre, New Delhi

110095

Institute of Human Behaviour and Allied Sciences, Delhi

210023

Vitebsk Regional Diagnostic Center, Vitebsk

380006

Neurology Center, Ahmedabad

400016

P.D. Hinduja National Hospital Medical Research Centre, Mumbai

400026

Jaslok Hospital & Research Centre, Mumbai

411004

Deenanath Mangeshkar Hospital and Research Center, Erandawane

560034

St. John's Medical College Hospital, Bangalore

575002

Malikatta Neuro Center, Mangalore

575018

K. S. Hedge Medical Academy, Mangalore

700054

Apollo Gleneagles Hospitals, Kolkata

1410108

Christian Medical College, Ludhiana

40536-0284

University of Kentucky, Kentucky Clinic, Department of Neurology, Lexington

02114

Massachusetts General Hospital, Boston

03756

Dartmouth-Hitchcock Medical Center, Lebanon

08901

Robert Wood Johnson University Hospital, New Brunswick

07503

St. Joseph's Regional Medical Center, Paterson

08043

Clinical Research Center of New Jersey (CRCNJ), Voorhees Township

23298-0211

Virginia Commonwealth University, Richmond

411 011

KEM Hospital & Research Centre, Pune

600 100

Dr. Kamakshi Memorial Hospital, Chennai

226 003

Chhatrapati Sahu Ji Maharaj Medical University, Lucknow

LT 50009

Kaunas University of Medicine Hospital, Kaunas

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Lundbeck LLC

INDUSTRY