Clobazam Use in Epilepsia Partialis Continua - Pilot Study
Epilepsia Partialis Continua, Kojewnikov's Epilepsy, Epilepsy
About this trial
This is an interventional treatment trial for Epilepsia Partialis Continua focused on measuring Epilepsia Partialis Continua, Kojewnikov's Epilepsy, Epilepsy, Clobazam, Focal Motor Epilepsy, Partial Motor Seizure
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)
Sites / Locations
- Cooper Universtiy Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Active Comparator
Clobazam
Clonazepam
Lorazepam
Subjects who are assigned the clobazam treatment group will receive a 10mg loading dose followed by a maintenance dose of 5-25 mg bid starting 12 hrs after the loading dose. If subjects are found to have failed to respond to treatment with clobazam, the physician investigator has the ability to either start another AED or increase the dose of clobazam depending on the clinical situation. Subjects still being treated with clobazam at discharge will be given a 30 day supply of clobazam.
Subjects who are assigned to the clonazepam treatment group will receive a dose of 1-2mg clonazepam dose tid. Following the initial treatment if a physician investigator determines that the subject's treatment has failed, the investigator has the option of treating the subject with clobazam at which point the individuals would be treated in the same method as those originally assigned to the clobazam treatment group.
Subjects who are assigned to the lorazepam treatment group will receive a 1-2mg dose of lorazepam qid. Following the initial treatment if a physician investigator determines that the subject's treatment has failed, the investigator has the option of treating the subject with clobazam at which point the individuals would be treated in the same method as those originally assigned to the clobazam treatment group.