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Clobazam Use in Epilepsia Partialis Continua - Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02134366
Recruitment Status : Terminated (Recruitment Issues - Lack of target population)
First Posted : May 9, 2014
Last Update Posted : May 9, 2018
Sponsor:
Collaborator:
Lundbeck LLC
Information provided by (Responsible Party):
The Cooper Health System

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.

Condition or disease Intervention/treatment Phase
Epilepsia Partialis Continua Kojewnikov's Epilepsy Epilepsy Drug: Clobazam Drug: Clonazepam Drug: Lorazepam Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2014
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017


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 Name: 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 Name: 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 Name: Klonopin

Drug: Lorazepam
Comparison of AED use in Epilepsia Partialis Continua
Other Names:
  • Ativan
  • Orfidal




Primary Outcome Measures :
  1. Time (measured in minutes) to onset of seizure freedom [ Time Frame: Within 7 days ]
  2. Reduction of seizure frequency/minute [ Time Frame: Within 7 days ]

Secondary Outcome Measures :
  1. Mental status preservation off sedating anticonvulsants as measured by the MoCA© scale [ Time Frame: Within 37 days ]
  2. Ambulatory function as measured by the Hauser Ambulation Index [ Time Frame: Within 37 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134366


Locations
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United States, New Jersey
Cooper Universtiy Hospital
Camden, New Jersey, United States, 08103
Sponsors and Collaborators
The Cooper Health System
Lundbeck LLC
Investigators
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Principal Investigator: Melissa Carran, MD Cooper University Health System

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Responsible Party: The Cooper Health System
ClinicalTrials.gov Identifier: NCT02134366    
Other Study ID Numbers: EPC-1
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Keywords provided by The Cooper Health System:
Epilepsia Partialis Continua
Kojewnikov's Epilepsy
Epilepsy
Clobazam
Focal Motor Epilepsy
Partial Motor Seizure
Additional relevant MeSH terms:
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Epilepsy
Epilepsia Partialis Continua
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Status Epilepticus
Seizures
Neurologic Manifestations
Signs and Symptoms
Lorazepam
Clonazepam
Clobazam
Anticonvulsants
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA-A Receptor Agonists
GABA Agonists