Clobazam Use in Epilepsia Partialis Continua - Pilot Study

• Status: Terminated
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cooper Health System
• Collaborator: Lundbeck LLC
• Treatments: Clobazam; Clonazepam; Lorazepam

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)