NCT02134366

Clobazam Use in Epilepsia Partialis Continua - Pilot Study

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: The Cooper Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Epilepsia Partialis Continua
• Kojewnikov's Epilepsy
• Epilepsy

Interventions

Type	Name	Description
DRUG	Clobazam	Comparison of AED use in Epilepsia Partialis Continua
DRUG	Clonazepam	Comparison of AED use in Epilepsia Partialis Continua
DRUG	Lorazepam	Comparison of AED use in Epilepsia Partialis Continua

Timeline

• Start date: 2014-07-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2014-05-09
• Last updated: 2018-05-09

Locations

1 site across 1 country: United States