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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02175173

Enrollment

707

Registered

2014-06-26

Start date

2013-06-13

Completion date

2022-11-02

Last updated

2023-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lennox-Gastaut Syndrome

Keywords

Epileptic encephalopathy, Lennox-Gastaut type

Brief 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.)

Interventions

DRUGRufinamide

Administration of Inovelon 100mg or 200mg Tablets

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

All patients with Lennox-Gastaut syndrome and administrated Inovelon

Design outcomes

Primary

Measure	Time frame
Investigations on adverse events and adverse drug reactions	Up to 2 years

Secondary

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026