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NCT02175173 Clinical Trial

Post-marketing Surveillance of Long-term Administration of Inovelon Tablets in Patients With Lennox-Gastaut Syndrome

Lennox-Gastaut Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02175173
Other study ID # INO01T
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 13, 2013
Est. completion date November 2, 2022

Study information
Verified date November 2022
Source Eisai Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This surveillance's objectives are 1. Unknown adverse reactions 2. Incidences of adverse drug reaction 3. Efficacy during long-term administration 4. Factors considered to have effect to safety and effectiveness 5. Incidences of status epileptics, skin disorders and hyper sensitivity reaction, and central nervous system-related adverse events(ataxia , somnolence and/or dizzy, etc.)

Recruitment information / eligibility
Status Completed
Enrollment 707
Est. completion date November 2, 2022
Est. primary completion date November 2, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility All patients with Lennox-Gastaut syndrome and administrated Inovelon

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Rufinamide
Administration of Inovelon 100mg or 200mg Tablets

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Investigations on adverse events and adverse drug reactions Up to 2 years
Secondary Frequency of attacks 12 weeks and every 6 months up to 2years
Secondary Overall assessments of the improvement in the seriousness of seizures 12 weeks and every 6 months up to 2years
See also
  Status Clinical Trial Phase
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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 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 NCT01160770 - Safety and Effectiveness of Open-Label Clobazam in Subjects With 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