Lennox Gastaut Syndrome MedDRA version: 13.1 Level: PT Classification code 10048816 Term: Lennox-Gastaut syndrome System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: rufinamide oral suspension
Product Code: rufinamide oral suspension
Pharmaceutical Form: Oral suspension
INN or Proposed INN: RUFINAMIDE
CAS Number: 106308-44-5
Current Sponsor code: E20
Sponsors
Eisai Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age = 1 and =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Familial short QT syndrome Prior treatment with rufinamide Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator(s) could affect the subject’s safety or study conduct Subject with hypersensivity to rufinamide and /or triazole or any of the excipients Any history of or concomitant medical condition that, in the opinion of the Investigator, would compromise the subject’s ability to safely complete the study Scheduled for surgery during the projected course of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of 2 drug regimens consisting of either rufinamide or any other approved AED of the investigator’s choice as an add-on to the subject’s existing regimen of 1-3 AEDs on the overall safety and tolerability of rufinamide in subjects aged 1 to less than 4 years of age with inadequately controlled LGS To characterize the age group specific pharmacokinetics of rufinamide in a pediatric population, 1 to less than 4 years of age, with inadequately controlled LGS, using the population approach To evaluate the effect of rufinamide as adjunctive treatment on the cognitive development and behavioral effects in a pediatric population, 1 to less than 4 years of age, with inadequately controlled LGS.;Secondary Objective: N/A;Primary end point(s): Primary efficacy variable: Change from baseline in CBCL Total Problems Score to the end of the 2-year (106 weeks) treatment period;Timepoint(s) of evaluation of this end point: Baseline to end of 2 year treatment period. Physical and neurological examinations (the latter only if possible) will be performed at screening, baseline, Visits 3, 4, 5, 7, 10, 12, 13, 14, and follow up/final visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
France, Greece, India, Italy, United States
Contacts
Public ContactMedical Information
Eisai Ltd
Outcome results
None listed