Clinical Trial: Post-marketing Surveillance of Long-term Administration of Inovelon Tablets in Patients With Lennox-Gastaut Syndrome
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational
Official Title:
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.)
Detailed Summary:
Sponsor: Eisai Co., Ltd.
Current Primary Outcome: Investigations on adverse events and adverse drug reactions [ Time Frame: Up to 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Frequency of attacks [ Time Frame: 12 weeks and every 6 monthsup to 2years ]
- Overall assessments of the improvement in the seriousness of seizures [ Time Frame: 12 weeks and every 6 monthsup to 2years ]
Original Secondary Outcome: Same as current
Information By: Eisai Inc.
Dates:
Date Received: June 10, 2014
Date Started: June 13, 2013
Date Completion: April 2018
Last Updated: February 20, 2017
Last Verified: January 2017
