Epilepsia Partialis Continua | Clobazam Use in Epilepsia Partialis Continua - Pilot Study
Epilepsia Partialis Continua research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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)
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Epilepsia Partialis Continua
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:ClobazamComparison of AED use in Epilepsia Partialis Continua
Drug:ClonazepamComparison of AED use in Epilepsia Partialis Continua
Drug:LorazepamComparison of AED use in Epilepsia Partialis Continua
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
ClobazamSubjects 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.
ClonazepamSubjects 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.
LorazepamSubjects 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.
Start Date: July 2014
Completed Date: July 2017
Phase: Phase 3
Primary Outcome: Time (measured in minutes) to onset of seizure freedom
Secondary Outcome: Mental status preservation off sedating anticonvulsants as measured by the MoCA© scale
Study sponsors, principal investigator, and references
Principal Investigator: Melissa Carran, MD
Lead Sponsor: The Cooper Health System
Collaborator: Lundbeck LLC