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Clobazam Use in Epilepsia Partialis Continua - Pilot Study

Primary Purpose

Epilepsia Partialis Continua, Kojewnikov's Epilepsy, Epilepsy

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Clobazam
Clonazepam
Lorazepam
Sponsored by
The Cooper Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Clobazam

Clonazepam

Lorazepam

Arm Description

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.

Outcomes

Primary Outcome Measures

Time (measured in minutes) to onset of seizure freedom
Reduction of seizure frequency/minute

Secondary Outcome Measures

Mental status preservation off sedating anticonvulsants as measured by the MoCA© scale
Ambulatory function as measured by the Hauser Ambulation Index

Full Information

First Posted
May 6, 2014
Last Updated
May 3, 2018
Sponsor
The Cooper Health System
Collaborators
Lundbeck LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02134366
Brief Title
Clobazam Use in Epilepsia Partialis Continua - Pilot Study
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 Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
Recruitment Issues - Lack of target population
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cooper Health System
Collaborators
Lundbeck LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsia Partialis Continua, Kojewnikov's Epilepsy, Epilepsy
Keywords
Epilepsia Partialis Continua, Kojewnikov's Epilepsy, Epilepsy, Clobazam, Focal Motor Epilepsy, Partial Motor Seizure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clobazam
Arm Type
Experimental
Arm Description
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.
Arm Title
Clonazepam
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Lorazepam
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Clobazam
Other Intervention Name(s)
Onfi, Frisium, Urbanol
Intervention Description
Comparison of AED use in Epilepsia Partialis Continua
Intervention Type
Drug
Intervention Name(s)
Clonazepam
Other Intervention Name(s)
Klonopin
Intervention Description
Comparison of AED use in Epilepsia Partialis Continua
Intervention Type
Drug
Intervention Name(s)
Lorazepam
Other Intervention Name(s)
Ativan, Orfidal
Intervention Description
Comparison of AED use in Epilepsia Partialis Continua
Primary Outcome Measure Information:
Title
Time (measured in minutes) to onset of seizure freedom
Time Frame
Within 7 days
Title
Reduction of seizure frequency/minute
Time Frame
Within 7 days
Secondary Outcome Measure Information:
Title
Mental status preservation off sedating anticonvulsants as measured by the MoCA© scale
Time Frame
Within 37 days
Title
Ambulatory function as measured by the Hauser Ambulation Index
Time Frame
Within 37 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Carran, MD
Organizational Affiliation
Cooper University Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cooper Universtiy Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States

12. IPD Sharing Statement

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Clobazam Use in Epilepsia Partialis Continua - Pilot Study

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