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Trial record 80 of 921 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. )

Tracking Information
First Submitted Date June 10, 2014
First Posted Date June 26, 2014
Last Update Posted Date February 5, 2019
Actual Study Start Date June 13, 2013
Estimated Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 24, 2014)
Investigations on adverse events and adverse drug reactions [ Time Frame: Up to 2 years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02175173 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 12, 2018)
  • Frequency of attacks [ Time Frame: 12 weeks and every 6 months up to 2years ]
  • Overall assessments of the improvement in the seriousness of seizures [ Time Frame: 12 weeks and every 6 months up to 2years ]
Original Secondary Outcome Measures
 (submitted: June 24, 2014)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Post-marketing Surveillance of Long-term Administration of Inovelon Tablets in Patients With Lennox-Gastaut Syndrome
Official Title Not Provided
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.)
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with Lennox-Gastaut Syndrome
Condition Lennox-Gastaut Syndrome
Intervention Drug: Rufinamide
Administration of Inoveron 100mg or 200mg Tablets
Other Name: Inoveron Tablet
Study Groups/Cohorts 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.
Intervention: Drug: Rufinamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 12, 2018)
728
Original Estimated Enrollment
 (submitted: June 24, 2014)
300
Estimated Study Completion Date July 1, 2019
Estimated Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria All patients with Lennox-Gastaut syndrome and administrated Inovelon
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Inquiry Service eisai-chiken_hotline@hhc.eisai.co.jp
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT02175173
Other Study ID Numbers INO01T
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Eisai Inc. ( Eisai Co., Ltd. )
Study Sponsor Eisai Co., Ltd.
Collaborators Not Provided
Investigators Not Provided
PRS Account Eisai Inc.
Verification Date July 2018