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Trial record 80 of 914 for:    tablet | Japan

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

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ClinicalTrials.gov Identifier: NCT02175173
Recruitment Status : Recruiting
First Posted : June 26, 2014
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

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.)

Condition or disease Intervention/treatment
Lennox-Gastaut Syndrome Drug: Rufinamide

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Study Type : Observational
Estimated Enrollment : 728 participants
Observational Model: Other
Time Perspective: Retrospective
Actual Study Start Date : June 13, 2013
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Rufinamide

Group/Cohort Intervention/treatment
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
Administration of Inoveron 100mg or 200mg Tablets
Other Name: Inoveron Tablet




Primary Outcome Measures :
  1. Investigations on adverse events and adverse drug reactions [ Time Frame: Up to 2 years ]

Secondary Outcome Measures :
  1. Frequency of attacks [ Time Frame: 12 weeks and every 6 months up to 2years ]
  2. Overall assessments of the improvement in the seriousness of seizures [ Time Frame: 12 weeks and every 6 months up to 2years ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Lennox-Gastaut Syndrome
Criteria
All patients with Lennox-Gastaut syndrome and administrated Inovelon

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175173


Contacts
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Contact: Inquiry Service eisai-chiken_hotline@hhc.eisai.co.jp

Locations
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Japan
Recruiting
Osaka, Japan
Recruiting
Tokyo, Japan
Sponsors and Collaborators
Eisai Co., Ltd.

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Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT02175173     History of Changes
Other Study ID Numbers: INO01T
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: July 2018

Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Epileptic encephalopathy, Lennox-Gastaut type

Additional relevant MeSH terms:
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Syndrome
Lennox Gastaut Syndrome
Disease
Pathologic Processes
Epileptic Syndromes
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Rufinamide
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action