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

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.)

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Key information

Conditions

Lennox-Gastaut Syndrome Brain Diseases Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Epilepsy Epileptic Syndromes Epileptic encephalopathy, Lennox-Gastaut type Genetic Diseases, Inborn Lennox Gastaut Syndrome Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Osaka, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

All patients with Lennox-Gastaut syndrome and administrated Inovelon

Treatment and study plan

Rufinamide

Drug

Administration of Inovelon 100mg or 200mg Tablets

Other names: Inovelon Tablet

Primary outcomes

Investigations on adverse events and adverse drug reactions

Time frame: Up to 2 years

Secondary outcomes

Frequency of attacks

Time frame: 12 weeks and every 6 months up to 2years
Overall assessments of the improvement in the seriousness of seizures

Time frame: 12 weeks and every 6 months up to 2years

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Important dates

Study start: 2013
Primary completion: 2022
Study completion: 2022
First posted: Jun 26, 2014
Registry last updated: Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed