Clobazam in Subjects With Lennox-Gastaut Syndrome
Safety and Efficacy of Clobazam in Subjects With Lennox-Gastaut Syndrome
2 other identifiers
interventional
68
1 country
14
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 subjects 2 to 30 years of age with Lennox-Gastaut Syndrome (LGS). Subjects will be enrolled at approximately 10 investigational sites in the U.S. for up to 15 weeks. Subjects will be randomly assigned to either a low dose or a high dose. The study will include a baseline period, a titration period and a maintenance period. After the maintenance period, subjects 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_2
Started Oct 2005
Shorter than P25 for phase_2
14 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
First Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 13, 2005
CompletedStudy Start
First participant enrolled
October 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedResults Posted
Study results publicly available
February 9, 2012
CompletedFebruary 9, 2012
January 1, 2012
10 months
September 9, 2005
November 7, 2011
January 6, 2012
Conditions
Outcome Measures
Primary Outcomes (2)
Percent Reduction in Number of Drop Seizures.
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 4-week maintenance period
A Comparison of the High Dose Group to Low Dose Group of the Percent Reduction in Number of Drop Seizures.
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 the 4-week maintenance period
Secondary Outcomes (3)
Percent of Patients Considered Treatment Responders Defined as Those With a >= 25%, >= 50%, >= 75%, and 100% Reduction in Drop Seizures.
4-week baseline period and 4-week maintenance period
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms.
Week 3
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms.
Week 7
Study Arms (2)
Clobazam Low Dose
EXPERIMENTALClobazam High Dose
EXPERIMENTALInterventions
5 to 10 mg/day with doses in the morning and at bedtime; orally
5 to 40 mg/day with doses in the morning and at bedtime; orally
Eligibility Criteria
You may qualify if:
- Subject must have been \<11 years of age at the onset of LGS
- Subject must have LGS
- Subject must be on at least 1 stable dose AED
- Parent or caregiver must be able to keep an accurate seizure diary
You may not qualify if:
- Etiology of subject's seizures is a progressive neurologic disease. Subjects with tuberous sclerosis will not be excluded from study participation
- Subject has had an episode of status epilepticus within 12 weeks of baseline
- Subject has had an anoxic episode requiring resuscitation within 1 year of screening
- Subject has had a clinically significant history of an allergic reaction or significant sensitivity to benzodiazepines
- Subject is taking more than 3 concurrent AEDs. Note: Vagal Nerve Stimulation (VNS) or ketogenic diet is allowed and each will be counted as one of the three allowed AEDs
- If the subject is on the ketogenic diet, has been for less than 4 weeks prior to screening or suffers from frequent stooling
- If the subject has a VNS, the settings have not been stable for at least 4 weeks prior to screening
- Subject has taken corticotropins in the 6 months prior to screening
- Subject is currently taking long-term systemic steroids (excluding inhaled medication for asthma treatment) or any other daily medication known to exacerbate epilepsy. An exception will be made of prophylactic medication, for example, for urinary tract infections or asthma
- If the subject is taking felbamate, has been taking it for less than 1 year prior to screening or previous treatment with felbamate resulted in withdrawal due to liver or bone marrow adverse events
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lundbeck LLClead
Study Sites (14)
Barrow Neurological Institute
Phoenix, Arizona, 85013, United States
Childrens Hospital Los Angeles
Los Angeles, California, 90027, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Pediatric Epilepsy & Neurology Specialists
Tampa, Florida, 33609, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Childrens Hospital Boston
Boston, Massachusetts, 02115, United States
Minnesota Epilepsy Group, P.A.
Saint Paul, Minnesota, 55102, United States
Children's Hospital
Columbus, Ohio, 43205, United States
University of Tennessee Health Science Center
Memphis, Tennessee, 38105, United States
Dallas Pediatric Neurology Associates
Dallas, Texas, 75230, United States
Texas Child Neurology, LLP
Plano, Texas, 75075, United States
Monarch Medical Research
Norfolk, Virginia, 23510, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53201, United States
Related Publications (1)
Conry JA, Ng YT, Paolicchi JM, Kernitsky L, Mitchell WG, Ritter FJ, Collins SD, Tracy K, Kormany WN, Abdulnabi R, Riley B, Stolle J. Clobazam in the treatment of Lennox-Gastaut syndrome. Epilepsia. 2009 May;50(5):1158-66. doi: 10.1111/j.1528-1167.2008.01935.x. Epub 2008 Dec 15.
PMID: 19170737BACKGROUND
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 2
- 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
September 9, 2005
First Posted
September 13, 2005
Study Start
October 1, 2005
Primary Completion
August 1, 2006
Study Completion
October 1, 2006
Last Updated
February 9, 2012
Results First Posted
February 9, 2012
Record last verified: 2012-01