DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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


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 freedom

Reduction of seizure frequency/minute

Secondary outcome:

Mental status preservation off sedating anticonvulsants as measured by the MoCA© scale

Ambulatory 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017