Clobazam Use in Epilepsia Partialis Continua - Pilot Study

First approved in the United States in 2011 for use in treating Lennox-Gastaut syndrome,
clobazam is the only 1, 5-benzodiazepine that is currently approved for clinical use in the
United States. In previous clinical trials clobazam has been shown to have a greater efficacy
and produce fewer side effects in individuals when it's adverse event profile is compared to
the traditional 1,4-benzodiazepines such as diazepam, lorazepam, and clonazepam. As a
benzodiazepine, clobazam has been found to have anticonvulsant properties, and structural
differences as a 1,5-benzodiazepines that appear to have a broader spectrum of anticonvulsant
activity than those found in 1,4-benzodiazepines. In previous reports, clobazam has been seen
to be effective in ether terminating or reducing both EPC in particular and partial status
epilepticus.

Inclusion Criteria:

•≥ to 18 yrs of age

•Diagnosis of EPC by a Neurologist

Exclusion Criteria:

- Previous exposure to clobazam prior to presentation

- Seizure generalization

- Patients who are intubated and on IV sedation such as Versed®, Propofol or Presedex®.

- Female subjects who are pregnant and/or breast-feeding

- Subject has an unstable and/or serious or psychiatric illness

- Subject has an unstable and/or serious medical illness

- Subject has any of the following but not limited to conditions:

- A life threatening medical condition

- Severe sepsis or septic shock

- Severe Renal impairment

- Severe Hepatic impairment

- Sleep apnea

- Narrow angle glaucoma

- Severe respiratory insufficiency

- Myasthenia gravis

- Metastatic cancer

- Organ failure

- Severe progressive nervous system disease

- A clinically significant EKG abnormality that would be affected by and/or affect
the patient's participation in the trial

- Subject has active suicidal ideation at Screening and Baseline visits

- Subject has a history of suicidal thoughts or behaviors, which would be indicated by a
positive response to questions 4 and/or 5 on the CSSR-S. Exclusionary actions include
but are not limited to:

- Previous intent to act on suicidal ideation with a specific plan

- Previous preparatory acts or behavior

- A previous actual attempt, interrupted attempt or aborted suicide attempt

- Subject has a history of alcohol and/or substance abuse in the previous 12 months, or
the subject is unable to refrain from alcohol and/or substance abuse during the study.

- Subject admits to present illicit drug use or has a positive drug screen

- Subject is currently enrolled in or has been enrolled in any clinical trial within the
past 30 days

- Subject has a known allergy to any component of the study medication(s)