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.
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 LGS and a combination of treatments is often required. Many patients with LGS are refractory to standard AED treatment. More effective and better tolerated treatment options are needed for this population of medically intractable epilepsy patients. Clobazam is unique in that it is the only non-1, 4-benzodiazepine used in the treatment of epilepsy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
68
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
Barrow Neurological Institute
Phoenix, Arizona, United States
Childrens Hospital Los Angeles
Los Angeles, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Pediatric Epilepsy & Neurology Specialists
Tampa, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Childrens Hospital Boston
Boston, Massachusetts, United States
Minnesota Epilepsy Group, P.A.
Saint Paul, Minnesota, United States
Children's Hospital
Columbus, Ohio, United States
University of Tennessee Health Science Center
Memphis, Tennessee, United States
Dallas Pediatric Neurology Associates
Dallas, Texas, United States
...and 4 more locations
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.
Time frame: 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.
Time frame: 4-week baseline period and the 4-week maintenance period
Percent of Patients Considered Treatment Responders Defined as Those With a >= 25%, >= 50%, >= 75%, and 100% Reduction in 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.
Time frame: 4-week baseline period and 4-week maintenance period
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms.
The parent/caregiver was asked to rate the patient's overall change in symptoms and overall change in seizure activity and Quality of Life since the beginning of clobazam treatment by checking "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", or "very much worse".
Time frame: Week 3
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms.
The parent/caregiver was asked to rate the patient's overall change in symptoms and overall change in seizure activity and Quality of Life since the beginning of clobazam treatment by checking "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", or "very much worse".
Time frame: Week 7
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