Clinical trial NCT02134366: Clobazam Use in Epilepsia Partialis Continua - Pilot Study
Official title: A Phase III, Randomized, Open Label, Single Center, Study on the Effects of Treatment of Epilepsia Partialis Continua With Clobazam Compared to Treatment With or in Addition to Lorazepam and/or Clonazepam
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Epilepsia Partialis Continua
Kojewnikov's Epilepsy
Epilepsy
Keywords: Epilepsia Partialis Continua
Kojewnikov's Epilepsy
Epilepsy
Clobazam
Focal Motor Epilepsy
Partial Motor Seizure
Lead sponsor: The Cooper Health System
Sponsor class: OTHER
Collaborators: name: Lundbeck LLC
First posted: 2014-05-09
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Time (measured in minutes) to onset of seizure freedom
timeFrame: Within 7 days
measure: Reduction of seizure frequency/minute
timeFrame: Within 7 days
Secondary outcomes:
measure: Mental status preservation off sedating anticonvulsants as measured by the MoCA© scale
timeFrame: Within 37 days
measure: Ambulatory function as measured by the Hauser Ambulation Index
timeFrame: Within 37 days
Other outcomes:
Locations:
city: Camden
country: United States
facility: Cooper Universtiy Hospital
state: New Jersey
Study officials:
affiliation: Cooper University Health System
name: Melissa Carran, MD
role: PRINCIPAL_INVESTIGATOR
References: