Clobazam Use in Epilepsia Partialis Continua - Pilot Study

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02134366
• Other study ID #: EPC-1
• Status: Terminated
• Phase: Phase 3
• Start date: July 2014
• Est. completion date: July 2017

Study information

• Verified date: May 2018
• Source: The Cooper Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Epilepsia Partialis Continua
• Epilepsy
• Kojewnikov's Epilepsy

Intervention

Drug:
• Clobazam
Comparison of AED use in Epilepsia Partialis Continua
• Clonazepam
Comparison of AED use in Epilepsia Partialis Continua
• Lorazepam
Comparison of AED use in Epilepsia Partialis Continua

Locations

Country	Name	City	State
United States	Cooper Universtiy Hospital	Camden	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
The Cooper Health System	Lundbeck LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time (measured in minutes) to onset of seizure freedom		Within 7 days
Primary	Reduction of seizure frequency/minute		Within 7 days
Secondary	Mental status preservation off sedating anticonvulsants as measured by the MoCA© scale		Within 37 days
Secondary	Ambulatory function as measured by the Hauser Ambulation Index		Within 37 days