Clobazam in Subjects With Lennox-Gastaut Syndrome
Condition: Epilepsy; Epilepsy, Generalized; Seizures
MeSH terms: Epilepsy; Seizures; Lennox Gastaut Syndrome; Epilepsy, Generalized
Intervention: Clobazam Low Dose; Clobazam High Dose
Intervention description: 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
Intervention MeSH terms: Clobazam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 68.0
Sex: All
Minimum age: 2 Years
Maximum age: 30 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  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 Criteria:

          -  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