Study of Rufinamide in Pediatric Subjects 1 to Less Than 4 Years of Age With Lennox-Gastaut Syndrome Inadequately Controlled With Other Anti-epileptic Drugs
Information source: Eisai Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lennox-Gastaut Syndrome
Intervention: Rufinamide (Drug); Any other approved AED (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Eisai Inc. Official(s) and/or principal investigator(s): Alexis Arzimanoglou Arzimanoglou, Principal Investigator, Affiliation: Hopital Femme-Mere-Enfant Service D'Epilepsie -5eme etage 59 Boulevard Pinel Bron, France
Summary
This study is designed to evaluate the cognitive effect, safety, and pharmacokinetics (PK)
of rufinamide on Lennox-Gastaut Syndrome inadequately controlled in pediatric subjects
already taking other anti-epileptic drugs.
Clinical Details
Official title: A Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Cognitive Development Effects and Safety, and Pharmacokinetics of Adjunctive Rufinamide Treatment in Pediatric Subjects 1 to Less Than 4 Years of Age With Inadequately Controlled Lennox-Gastaut Syndrome
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in Child Behavior Checklist (CBCL) Total Problems Score
Secondary outcome: Time to withdrawal from rufinamide or other AEDPercent change in total seizure frequency and in frequency by individual type per 28 days Worsening of seizures Change in CBCL subscores Change in Language Development Survey score during Maintenance Period Change from Baseline in total and sub-scores of the Quality of Life in Childhood Epilepsy (QoLCE) scale.
Eligibility
Minimum age: 1 Year.
Maximum age: 3 Years.
Gender(s): Both.
Criteria:
Key Inclusion:
1. Clinical diagnosis of LGS at screening, which might include the presence of a slow
background electroencephalogram (EEG) rhythm, slow spikes-waves pattern (less than 3
Hz), the presence of polyspikes; care should be taken not to include benign myoclonic
epilepsy of infancy, subjects with a diagnosis of atypical benign partial epilepsy
(pseudo-Lennox syndrome), or continuous spike-waves of slow sleep (CSWS).
2. On a fixed dose of one to three concomitant regionally approved antiepileptic drugs
(AEDs) for a minimum of 8 weeks prior to randomization with an inadequate response to
treatment.
3. Consistent seizure documentation (i. e., no uncertainty of the presence of seizures)
and AED treatment documentation during the 8 week pre-randomization period.
Key Exclusion:
1. Familial short QT syndrome
2. Prior treatment with rufinamide
Locations and Contacts
Bron, France
Marseille, France
Paris, France
Pendeli Athens, Greece
Thessaloniki, Greece
Elblag, Poland
Gdansk, Poland
Kielce, Poland
Poznan, Poland
Edmonton, Alberta, Canada
Washington, District of Columbia, United States
Tampa, Florida, United States
Wellington, Florida, United States
Lexington, Kentucky, United States
Mantua, MN, Italy
Akron, Ohio, United States
Columbus, Ohio, United States
Calambrone, PI, Italy
Pavia, PV, Italy
Roma, RM, Italy
San Antonio, Texas, United States
Norfolk, Virginia, United States
Additional Information
Starting date: June 2011
Last updated: May 26, 2015
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