Clobazam Use in Epilepsia Partialis Continua - Pilot Study
Information source: The Cooper Health System
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsia Partialis Continua; Kojewnikov's Epilepsy; Epilepsy
Intervention: Clobazam (Drug); Clonazepam (Drug); Lorazepam (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: The Cooper Health System Official(s) and/or principal investigator(s): Melissa Carran, MD, Principal Investigator, Affiliation: Cooper University Health System
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Time (measured in minutes) to onset of seizure freedomReduction of seizure frequency/minute
Secondary outcome: Mental status preservation off sedating anticonvulsants as measured by the MoCA© scaleAmbulatory function as measured by the Hauser Ambulation Index
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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)
Locations and Contacts
Cooper Universtiy Hospital, Camden, New Jersey 08103, United States; Not yet recruiting Melissa Carran, MD Cory Hackmyer, BS, Phone: 856-342-2460, Email: hackmyer-cory@cooperhealth.edu Melissa Carran, MD, Principal Investigator Evren Burakgazi-Dalkilic, MD, Sub-Investigator Ruchir Shah, MD, Sub-Investigator George Shokri, MD, Sub-Investigator Cory Hackmyer, BS, Sub-Investigator Tamara D Lee, BS, CCRP, Sub-Investigator Krystal Hunter, MBA, Sub-Investigator
Additional Information
Starting date: July 2014
Last updated: May 7, 2014
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