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

NCT02175173 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 707

Last updated 2023-02-21

No results posted yet for this study

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

DRUG

Rufinamide

Administration of Inovelon 100mg or 200mg Tablets

Sponsors & Collaborators

  • Eisai Co., Ltd.

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-13
Primary Completion
2022-11-02
Completion
2022-11-02

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02175173 on ClinicalTrials.gov