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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 AED

Percent 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

Page last updated: August 23, 2015

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