Recruitment Issues - Lack of target population

The purpose of this study is to evaluate whether clobazam, brand name Onf®, is more effective as an adjunctive or monotherapy in terminating Epilepsia Partialis Continua (EPC) than either lorazepam and/or clonazepam.

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)