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

NCT02175173 | Completed

• 1 other identifier: INO01T
• Study Type: observational
• Target: 707
• Locations: 1 country
• Sites: 2

Brief Summary

This surveillance's objectives are

1. 1.Unknown adverse reactions
2. 2.Incidences of adverse drug reaction
3. 3.Efficacy during long-term administration
4. 4.Factors considered to have effect to safety and effectiveness
5. 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

Keywords

Epileptic encephalopathy, Lennox-Gastaut type

Outcome Measures

Primary Outcomes (1)

• Investigations on adverse events and adverse drug reactions

  Up to 2 years

Secondary Outcomes (2)

• 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

Study Arms (1)

E2080

Children ages \>= 4 years: Patients weighing 15.0-30.0 kg: oral daily dose of 200 mg in two divided doses after meals for the first 2 days. The dose will be increased by up to 200 mg/day every two days. The maintenance dose should be 1000 mg/day in two divided doses after meals. The dose can be increased or decreased within a range not exceeding 1000 mg/day, and should be increased by up to 200 mg/day at intervals not less than 2 days. Patients weighing \>= 30.1 kg: Adults: oral daily dose of 400 mg in two divided doses after meals for the first 2 days, then increased by up to 400 mg/day every two days. The maintenance dose should be 1800 mg/day for patients weighing 30.1-50.0 kg, 2400 mg/day for patients weighing 50.1-70.0 kg, and 3200 mg/day for patients weighing 70.1 kg or over in two divided doses after meals. Dose can be increased or decreased within a range not exceeding the above maintenance dose, and should be increased by up to 400 mg/day at intervals not less than 2 days.

Drug: Rufinamide

Interventions

Rufinamide DRUG

Administration of Inovelon 100mg or 200mg Tablets

Also known as: Inovelon Tablet

E2080

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Lennox-Gastaut Syndrome

All patients with Lennox-Gastaut syndrome and administrated Inovelon

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (2)

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Tokyo, Japan

Location

MeSH Terms

Conditions

Lennox Gastaut Syndrome; Epileptic encephalopathy, Lennox-Gastaut type

Interventions

rufinamide

Condition Hierarchy (Ancestors)

Epileptic Syndromes; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: June 26, 2014
• Study Start: June 13, 2013
• Primary Completion: November 2, 2022
• Study Completion: November 2, 2022
• Last Updated: February 21, 2023

Record last verified: 2022-11

Locations

JP (2)