Status:
COMPLETED
Clobazam in Subjects With Lennox-Gastaut Syndrome
Lead Sponsor:
Lundbeck LLC
Conditions:
Epilepsy
Epilepsy, Generalized
Eligibility:
All Genders
2-30 years
Phase:
PHASE2
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 ...
Detailed Description
LGS poses a significant treatment challenge. While antiepileptic medications are the mainstay of treatment, no one antiepileptic drug (AED) provides satisfactory relief for all or most patients with L...
Eligibility Criteria
Inclusion
- Key
- 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
- Key
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00162981
Start Date
October 1 2005
End Date
October 1 2006
Last Update
February 9 2012
Active Locations (14)
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1
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
2
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
3
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
4
Pediatric Epilepsy & Neurology Specialists
Tampa, Florida, United States, 33609