CompletedInterventionalPhase 3Updated Nov 17, 2025
Post-marketing Surveillance of Long-term Administration of Inovelon Tablets in Patients With Lennox-Gastaut Syndrome | NCT02175173 | Trialant
CompletedObservationalUpdated Feb 21, 2023
Post-marketing Surveillance of Long-term Administration of Inovelon Tablets in Patients With Lennox-Gastaut Syndrome
ClinicalTrials.gov ID
NCT02175173
Lead Sponsor
Eisai Co., Ltd.INDUSTRY
Overall Status
Completed
Study Type
Observational
Enrollment
707Actual
Last Update Posted
Feb 21, 2023Actual
Start Date
Jun 13, 2013Actual
Primary Completion Date
Nov 2, 2022Actual
Completion Date
Nov 2, 2022Actual
Brief Summary
This surveillance's objectives are
Unknown adverse reactions
Incidences of adverse drug reaction
Efficacy during long-term administration
Factors considered to have effect to safety and effectiveness
Incidences of status epileptics, skin disorders and hyper sensitivity reaction, and central nervous system-related adverse events(ataxia , somnolence and/or dizzy, etc.)
Lennox-Gastaut Syndrome
Rufinamide
Ages Eligible for Study
Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
All patients with Lennox-Gastaut syndrome and administrated Inovelon