Clinical Trial: Clobazam Use in Epilepsia Partialis Continua - Pilot Study

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

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 Additi

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.

Detailed Summary: 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.
Sponsor: The Cooper Health System

Current Primary Outcome:

  • Time (measured in minutes) to onset of seizure freedom [ Time Frame: Within 7 days ]
  • Reduction of seizure frequency/minute [ Time Frame: Within 7 days ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Mental status preservation off sedating anticonvulsants as measured by the MoCA© scale [ Time Frame: Within 37 days ]
  • Ambulatory function as measured by the Hauser Ambulation Index [ Time Frame: Within 37 days ]


Original Secondary Outcome: Same as current

Information By: The Cooper Health System

Dates:
Date Received: May 6, 2014
Date Started: July 2014
Date Completion:
Last Updated: May 7, 2014
Last Verified: May 2014