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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

This study has been completed.
Information provided by (Responsible Party):
Eisai Inc. Identifier:
First received: July 27, 2011
Last updated: March 21, 2016
Last verified: February 2016
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.

Condition Intervention Phase
Lennox-Gastaut Syndrome
Drug: Rufinamide
Drug: Any other approved AED
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Change in Child Behavior Checklist (CBCL) Total Problems Score [ Time Frame: Baseline to the end of the Treatment Period (=106 weeks) ]

Secondary Outcome Measures:
  • Time to withdrawal from rufinamide or other AED [ Time Frame: Baseline to the end of the Treatment Period (=106 weeks) ]
  • Percent change in total seizure frequency and in frequency by individual type per 28 days [ Time Frame: Baseline to the end of the Treatment Period (=106 weeks) ]
  • Worsening of seizures [ Time Frame: Baseline to the end of the Treatment Period (=106 weeks) ]
  • Change in CBCL subscores [ Time Frame: Baseline to the end of the Treatment Period (=106 weeks) ]
  • Change in Language Development Survey score during Maintenance Period [ Time Frame: Baseline to the end of the Treatment Period (=106 weeks) ]
  • Change from Baseline in total and sub-scores of the Quality of Life in Childhood Epilepsy (QoLCE) scale. [ Time Frame: Baseline to the end of the Treatment Period (=106 weeks) ]

Enrollment: 37
Study Start Date: June 2011
Study Completion Date: November 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rufinamide Drug: Rufinamide
rufinamide up to 45 mg/kg/day, in 2 divided doses, administered as oral suspension (40 mg/mL) as an add-on to the subject's existing regimen of 1-3 antiepileptic drugs (AEDs)
Active Comparator: Any other approved AED Drug: Any other approved AED
Any other approved AED: any other approved AED of the investigator's choice as an add-on to the subject's existing regimen of 1-3 anti-epileptic drugs (AEDs)


Ages Eligible for Study:   1 Year to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01405053

United States, District of Columbia
Washington, District of Columbia, United States
United States, Florida
Tampa, Florida, United States
Wellington, Florida, United States
United States, Kentucky
Lexington, Kentucky, United States
United States, Ohio
Akron, Ohio, United States
Columbus, Ohio, United States
United States, Texas
San Antonio, Texas, United States
United States, Virginia
Norfolk, Virginia, United States
Canada, Alberta
Edmonton, Alberta, Canada
Bron, France
Marseille, France
Paris, France
Pendeli Athens, Greece
Thessaloniki, Greece
Mantua, MN, Italy
Calambrone, PI, Italy
Pavia, PV, Italy
Roma, RM, Italy
Elblag, Poland
Gdansk, Poland
Kielce, Poland
Poznan, Poland
Sponsors and Collaborators
Eisai Inc.
Principal Investigator: Alexis Arzimanoglou Arzimanoglou Hopital Femme-Mere-Enfant Service D'Epilepsie -5eme etage 59 Boulevard Pinel Bron, France
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Eisai Inc. Identifier: NCT01405053     History of Changes
Other Study ID Numbers: E2080-G000-303
Study First Received: July 27, 2011
Last Updated: March 21, 2016

Keywords provided by Eisai Inc.:
Central Nervous System

Additional relevant MeSH terms:
Lennox Gastaut Syndrome
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Anticonvulsants processed this record on May 22, 2017