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

Status: Terminated
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• •≥ to 18 yrs of age

• •Diagnosis of EPC by a Neurologist

Locations
United States
New Jersey
Cooper Universtiy Hospital
Camden
Time Frame
Start Date: 2014-07
Completion Date: 2017-07
Participants
Target number of participants: 7
Treatments
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.
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.
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.
Sponsors
Collaborators: Lundbeck LLC
Leads: The Cooper Health System

This content was sourced from clinicaltrials.gov