Clobazam Use in Epilepsia Partialis Continua - Pilot Study

May 3, 2018 updated by: The Cooper Health System

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper Universtiy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clobazam
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.
Drug: Clobazam
Comparison of AED use in Epilepsia Partialis Continua
Other Names:
  • Onfi
  • Frisium
  • Urbanol
Drug: Clonazepam
Comparison of AED use in Epilepsia Partialis Continua
Other Names:
  • Klonopin
Drug: Lorazepam
Comparison of AED use in Epilepsia Partialis Continua
Other Names:
  • Ativan
  • Orfidal
Active Comparator: Clonazepam
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.
Drug: Clobazam
Comparison of AED use in Epilepsia Partialis Continua
Other Names:
  • Onfi
  • Frisium
  • Urbanol
Drug: Clonazepam
Comparison of AED use in Epilepsia Partialis Continua
Other Names:
  • Klonopin
Drug: Lorazepam
Comparison of AED use in Epilepsia Partialis Continua
Other Names:
  • Ativan
  • Orfidal
Active Comparator: Lorazepam
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.
Drug: Clobazam
Comparison of AED use in Epilepsia Partialis Continua
Other Names:
  • Onfi
  • Frisium
  • Urbanol
Drug: Clonazepam
Comparison of AED use in Epilepsia Partialis Continua
Other Names:
  • Klonopin
Drug: Lorazepam
Comparison of AED use in Epilepsia Partialis Continua
Other Names:
  • Ativan
  • Orfidal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time (measured in minutes) to onset of seizure freedom
Time Frame: Within 7 days
Within 7 days
Reduction of seizure frequency/minute
Time Frame: Within 7 days
Within 7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Mental status preservation off sedating anticonvulsants as measured by the MoCA© scale
Time Frame: Within 37 days
Within 37 days
Ambulatory function as measured by the Hauser Ambulation Index
Time Frame: Within 37 days
Within 37 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cooper Health System

Collaborators

Lundbeck LLC

Investigators

  • Principal Investigator: Melissa Carran, MD, Cooper University Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

May 6, 2014

First Submitted That Met QC Criteria

May 7, 2014

First Posted (Estimate)

May 9, 2014

Study Record Updates

Last Update Posted (Actual)

May 9, 2018

Last Update Submitted That Met QC Criteria

May 3, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPC-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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