Clobazam in Patients With Lennox-Gastaut Syndrome
Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Clobazam in Patients With Lennox-Gastaut Syndrome
2 other identifiers
interventional
238
5 countries
53
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of clobazam as adjunctive therapy in the treatment of seizures which lead to drop attacks (drop seizures) in patients 2 to 60 years of age with Lennox-Gastaut Syndrome (LGS). Patients will be enrolled at approximately 65 sites in the U.S. and ex-US for up to 23 weeks. Patients will be randomly assigned to either a low, medium or high dose, or placebo. The study will include a baseline period, a titration period and a maintenance period. After the maintenance period, patients will either continue into an open-label extension study or enter the taper period with a final visit 1 week after the last dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2007
Typical duration for phase_3
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 20, 2007
CompletedFirst Posted
Study publicly available on registry
August 21, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
February 9, 2012
CompletedFebruary 9, 2012
January 1, 2012
2.3 years
August 20, 2007
November 7, 2011
January 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Reduction in Number of Drop Seizures (12-week Maintenance Period).
Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.
4-week baseline period and 12-week maintenance period
Secondary Outcomes (10)
Percent Reduction in Number of Drop Seizures (First 4 Weeks of the 12-week Maintenance Period).
4-week baseline period and the first 4 weeks of the 12-week maintenance period
Percent Reduction in Number of Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period).
4-week baseline period and the middle 4 weeks of the 12-week maintenance period
Percent Reduction in Number of Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period).
4-week baseline period and the last 4 weeks of the 12-week maintenance period
Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (12-week Maintenance Period).
4-week baseline period and the 12-week maintenance period
Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (First 4 Weeks of the 12-week Maintenance Period).
4-week baseline period and the first 4 weeks of the 12-week maintenance period
- +5 more secondary outcomes
Other Outcomes (2)
Percent Reduction in the Number of Non-drop Seizures.
4-week baseline period and the 12-week maintenance period
Percent Reduction of Total (Drop and Non-Drop) Seizures.
4-week baseline period and 12-week maintenance period
Study Arms (4)
Clobazam Low Dose
EXPERIMENTALClobazam Medium Dose
EXPERIMENTALClobazam High Dose
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
0.25 mg/kg/day; tablets; orally; for 15-18 weeks
0.5 mg/kg/day; tablets; orally; for 15-18 weeks
1.0 mg/kg/day; tablets; orally; for 15-18 weeks
Eligibility Criteria
You may qualify if:
- Patient must have been \<11 years of age at the onset of LGS.
- Patient must have LGS.
- Patient must be on at least 1 AED.
- Parent or caregiver must be able to keep an accurate seizure diary.
You may not qualify if:
- Etiology of patient's seizures is a progressive neurologic disease. Patients with tuberous sclerosis will not be excluded from study participation, unless there is a progressive tumor.
- Patient has had an episode of status epilepticus within 12 weeks of baseline.
- Patient has had an anoxic episode requiring resuscitation within 6 months of screening.
- Patient has a clinically significant history of an allergic reaction or significant sensitivity to benzodiazepines.
- Patient is taking more than 3 concurrent AEDs.
- Patient has been on the ketogenic diet for less than 30 days prior to screening or suffers from frequent stooling.
- If the patient has a Vagal Nerve Stimulator (VNS), the settings have not been stable for at least 30 days prior to screening.
- Patient has taken corticotropins in the 6 months prior to screening.
- Patient is currently taking long-term systemic steroids (excluding inhaled mediation for asthma treatment) or any other daily medication known to exacerbate epilepsy. An exception will be made of prophylactic medication, for example, for idiopathic nephrotic syndrome or asthma.
- If the patient is taking felbamate, has been taking it for less than 1 year prior to screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lundbeck LLClead
Study Sites (53)
University of Alabama at Birmingham
Huntsville, Alabama, 35081, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
Phoenix Children's Hospital
Phoenix, Arizona, 85216, United States
Childrens Hospital Los Angeles
Los Angeles, California, 90027, United States
The Children's Hospital
Aurora, Colorado, 80045, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Pediatric Neurology and Epilepsy Center
Loxahatchee Groves, Florida, 33470, United States
Child Neurology Center of NW FL
Pensacola, Florida, 32504, United States
University of South Florida
Tampa, Florida, 33606, United States
Pediatric Epilepsy & Neurology Specialists
Tampa, Florida, 33609, United States
Medical College of Georgia
Augusta, Georgia, 30912, United States
Pediatric Neurology of Idaho Children's Specialty Center
Boise, Idaho, 83712, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Children's Memorial Hospital
Chicago, Illinois, 61516, United States
University of Kentucky, Kentucky Clinic, Department of Neurology
Lexington, Kentucky, 40536-0284, United States
LSU Health Sciences Center
Shreveport, Louisiana, 71103, United States
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, 20817, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Minnesota Epilepsy Group
Saint Paul, Minnesota, 55012, United States
The Comprehensive Epilepsy Care Center for Children and Adults
Chesterfield, Missouri, 63017, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901, United States
St. Joseph's Regional Medical Center
Paterson, New Jersey, 07503, United States
Clinical Research Center of New Jersey (CRCNJ)
Voorhees Township, New Jersey, 08043, United States
University of Rochester Medical Center
Rochester, New York, 14450, United States
University Neurology, Inc.
Cincinnati, Ohio, 45219, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Jefferson Epilepsy Center
Philadelphia, Pennsylvania, 19107, United States
UTMG Pediatric Neurology
Memphis, Tennessee, 38105, United States
Children's Medical Center at UT Southwestern-Dallas
Dallas, Texas, 75235, United States
Cook Children's Health Care System
Fort Worth, Texas, 76104, United States
Baylor College of Medicine Pediatric Neurology
Houston, Texas, 77030, United States
Virginia Commonwealth University
Richmond, Virginia, 23298-0211, United States
Strategic Health Evaluators
Chatswood, New South Wales, 2067, Australia
Royal Melbourne Hospital Department of Neurology
Melbourne, Victoria, 3050, Australia
Austin & Repatriation Hospital (Austin Health) Epilepsy Research Centre
Melbourne, Victoria, 3081, Australia
Vitebsk Regional Diagnostic Center
Vitebsk, 210023, Belarus
Neurology Center
Ahmedabad, Gujarat, 380006, India
St. John's Medical College Hospital
Bangalore, Karnataka, 560034, India
Malikatta Neuro Center
Mangalore, Karnataka, 575002, India
K. S. Hedge Medical Academy
Mangalore, Karnataka, 575018, India
Jaslok Hospital & Research Centre
Mumbai, Maharashtra, 400026, India
KEM Hospital & Research Centre
Pune, Maharashtra, 411 011, India
P.D. Hinduja National Hospital Medical Research Centre
Mumbai, Mumbai, 400016, India
Maulana Azad Medical College and Associated Lok Nayak Govind Ballabh Pant Hospitals and Guru Nanak Eye centre
New Delhi, National Capital Territory of Delhi, 110002, India
Institute of Human Behaviour and Allied Sciences
Delhi, New Delhi, 110095, India
Deenanath Mangeshkar Hospital and Research Center
Erandawane, Pune, 411004, India
Christian Medical College
Ludhiana, Punjab, 1410108, India
Dr. Kamakshi Memorial Hospital
Chennai, Tamil Nadu, 600 100, India
Chhatrapati Sahu Ji Maharaj Medical University
Lucknow, Uttra Pradesh, 226 003, India
Apollo Gleneagles Hospitals
Kolkata, West Bengal, 700054, India
Kaunas University of Medicine Hospital
Kaunas, LT 50009, Lithuania
Related Publications (3)
Ng YT, Conry JA, Drummond R, Stolle J, Weinberg MA; OV-1012 Study Investigators. Randomized, phase III study results of clobazam in Lennox-Gastaut syndrome. Neurology. 2011 Oct 11;77(15):1473-81. doi: 10.1212/WNL.0b013e318232de76. Epub 2011 Sep 28.
PMID: 21956725RESULTBrigo F, Jones K, Eltze C, Matricardi S. Anti-seizure medications for Lennox-Gastaut syndrome. Cochrane Database Syst Rev. 2021 Apr 7;4(4):CD003277. doi: 10.1002/14651858.CD003277.pub4.
PMID: 33825230DERIVEDGidal BE, Wechsler RT, Sankar R, Montouris GD, White HS, Cloyd JC, Kane MC, Peng G, Tworek DM, Shen V, Isojarvi J. Deconstructing tolerance with clobazam: Post hoc analyses from an open-label extension study. Neurology. 2016 Oct 25;87(17):1806-1812. doi: 10.1212/WNL.0000000000003253. Epub 2016 Sep 28.
PMID: 27683846DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Email contact via H. Lundbeck A/S
- Organization
- Lundbeck LLC
Study Officials
- STUDY DIRECTOR
Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@lundbeck.com
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2007
First Posted
August 21, 2007
Study Start
August 1, 2007
Primary Completion
December 1, 2009
Study Completion
April 1, 2010
Last Updated
February 9, 2012
Results First Posted
February 9, 2012
Record last verified: 2012-01