NCT02175173

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 707 (actual)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.)

Conditions

• Lennox-Gastaut Syndrome

Interventions

Type	Name	Description
DRUG	Rufinamide	Administration of Inovelon 100mg or 200mg Tablets

Timeline

• Start date: 2013-06-13
• Primary completion: 2022-11-02
• Completion: 2022-11-02
• First posted: 2014-06-26
• Last updated: 2023-02-21

Locations

2 sites across 1 country: Japan