Clobazam Use in Epilepsia Partialis Continua - Pilot Study

Stopped early · Phase 3

Conditions studied: Epilepsia Partialis Continua, Kojewnikov's Epilepsy, Epilepsy

In brief

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.

Key facts

Study ID

NCT02134366

Run by

The Cooper Health System

People needed

7

Starts

2014-07-01

Expected to finish

2017-07-01

Last updated by the study team

2018-05-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ to 18 yrs of age
• Diagnosis of EPC by a Neurologist

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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