Clinical Trials Logo
  1. Home
  2. Lennox-Gastaut Syndrome
  3. NCT01160770

Safety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut Syndrome — LGS  

Lennox-Gastaut Syndrome Clinical Trial

Official title:
Safety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut Syndrome

Clinical Trial Summary

The objective of this study is to evaluate the long-term safety and effectiveness of open-label clobazam in the treatment of drop seizures in subjects with LGS.

Clinical Trial Description

This multi-center, open-label study is designed to evaluate the long-term safety and effectiveness of clobazam as adjunctive therapy in subjects with LGS. Subjects enrolled in Lundbeck LLC (formerly Ovation Pharmaceuticals, Inc.) sponsored studies 13108A/OV1002/NCT00162981 and 13110A/OV1012/NCT00518713 who either completed the study or who prematurely discontinued were offered the opportunity to rollover into this open-label study. Subjects will start at a common dose level of 0.5 mg/kg, not to exceed 40 mg/day, and must maintain the dose level for 48 hours. After 48 hours, investigators will be able to increase, decrease or maintain the subject's dose, up to a maximum target daily dose of 2.0 mg/kg (maximum dose of 80 mg/day). During the treatment period, seizures will be recorded during the week preceding each study visit or 30 days immediately following each study visit (dependent on Amendment approval). The subject or subject's caregiver will record daily counts of seizures, including drop seizures in the subject's seizure diary. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01160770
Study type Interventional
Source Lundbeck LLC
Contact
Status Completed
Phase Phase 3
Start date December 2005
Completion date February 2012
View Details
See also
  Status Clinical Trial Phase
Withdrawn NCT04133480 - Investigation of Cognitive Outcomes With Cannabidiol Oral Solution Phase 4
Recruiting NCT02632149 - Trial to Assess Vagus Nerve Stimulation Therapy in Children With Lennox-Gastaut Syndrome Phase 0
Active, not recruiting NCT05626634 - Open-label, Long-term Safety Study of LP352 in Subjects With Developmental and Epileptic Encephalopathy Phase 2
Completed NCT01151540 - A Long Term Extension Study of E2080 in Lennox-Gastaut Patients Phase 3
Completed NCT00552045 - Epilepsy Phenome/Genome Project
Completed NCT00004776 - Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Topiramate for Lennox-Gastaut Syndrome Phase 3
Withdrawn NCT03254680 - Turmeric as Treatment in Epilepsy N/A
Completed NCT01146951 - A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients (Study E2080-J081-304) Phase 3
Completed NCT01991041 - European Registry of Anti-Epileptic Drug Use in Patients With Lennox-Gastaut Syndrome (LGS) N/A
Completed NCT01405053 - Study of Rufinamide in Pediatric Subjects 1 to Less Than 4 Years of Age With Lennox-Gastaut Syndrome Inadequately Controlled With Other Anti-epileptic Drugs Phase 3
Completed NCT02175173 - Post-marketing Surveillance of Long-term Administration of Inovelon Tablets in Patients With Lennox-Gastaut Syndrome
Completed NCT02224573 - An Open Label Extension Study of Cannabidiol (GWP42003-P) in Children and Adults With Dravet or Lennox-Gastaut Syndromes Phase 3
Completed NCT00004729 - Ketogenic Diet for Child Epilepsy and Seizure Control N/A
Terminated NCT02815540 - The Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in Children With Severe Epilepsy Phase 1/Phase 2
Withdrawn NCT02318537 - Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Participants With Inadequately Controlled Lennox-Gastaut Syndrome Phase 3
Completed NCT03650452 - A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies Phase 2
Withdrawn NCT01370486 - Melatonin Versus Placebo in the Lennox-Gastaut Syndrome: Neurophysiological and Neuropsychological Effects Phase 4
Completed NCT02731300 - Transcranial Direct Current Stimulation, Treatment of Childhood Drug-Resistant Lennox-Gastaut Syndrome, A Pilot Study Phase 4
Completed NCT02224690 - A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults Phase 3