Epilepsia Partialis Continua, Kojewnikov's Epilepsy, Epilepsy
Conditions
Keywords
Epilepsia Partialis Continua, Kojewnikov's Epilepsy, Epilepsy, Clobazam, Focal Motor Epilepsy, Partial Motor Seizure
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.
Interventions
DRUGClobazam
Comparison of AED use in Epilepsia Partialis Continua
DRUGClonazepam
Comparison of AED use in Epilepsia Partialis Continua
DRUGLorazepam
Comparison of AED use in Epilepsia Partialis Continua
Sponsors
Lundbeck LLC
The Cooper Health System
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time (measured in minutes) to onset of seizure freedom | Within 7 days |
| Reduction of seizure frequency/minute | Within 7 days |
Secondary
| Measure | Time frame |
|---|---|
| Mental status preservation off sedating anticonvulsants as measured by the MoCA© scale | Within 37 days |
| Ambulatory function as measured by the Hauser Ambulation Index | Within 37 days |
Countries
United States
Outcome results
None listed