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

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Lennox-Gastaut Syndrome	Drug: Rufinamide; Drug: Any other approved AED	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	37 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	June 2011
Actual Primary Completion Date :	October 2015
Actual Study Completion Date :	November 2015

Arms and Interventions

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Arm	Intervention/treatment
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)

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Time to withdrawal from rufinamide or other AED [ Time Frame: Baseline to the end of the Treatment Period (=106 weeks) ]
2. 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) ]
3. Worsening of seizures [ Time Frame: Baseline to the end of the Treatment Period (=106 weeks) ]
4. Change in CBCL subscores [ Time Frame: Baseline to the end of the Treatment Period (=106 weeks) ]
5. Change in Language Development Survey score during Maintenance Period [ Time Frame: Baseline to the end of the Treatment Period (=106 weeks) ]
6. 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) ]

Eligibility Criteria

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

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

Contacts and Locations

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Locations

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
France
Bron, France
Marseille, France
Paris, France
Greece
Pendeli Athens, Greece
Thessaloniki, Greece
Italy
Mantua, MN, Italy
Calambrone, PI, Italy
Pavia, PV, Italy
Roma, RM, Italy
Poland
Elblag, Poland
Gdansk, Poland
Kielce, Poland
Poznan, Poland

Sponsors and Collaborators

Eisai Inc.

Investigators

Principal Investigator:	Alexis Arzimanoglou Arzimanoglou	Hopital Femme-Mere-Enfant Service D'Epilepsie -5eme etage 59 Boulevard Pinel Bron, France

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Arzimanoglou A, Ferreira JA, Satlin A, Mendes S, Williams B, Critchley D, Schuck E, Hussein Z, Kumar D, Dhadda S, Bibbiani F. Safety and pharmacokinetic profile of rufinamide in pediatric patients aged less than 4 years with Lennox-Gastaut syndrome: An interim analysis from a multicenter, randomized, active-controlled, open-label study. Eur J Paediatr Neurol. 2016 May;20(3):393-402. doi: 10.1016/j.ejpn.2015.12.015. Epub 2016 Jan 11.

Responsible Party:	Eisai Inc.
ClinicalTrials.gov Identifier:	NCT01405053 History of Changes
Other Study ID Numbers:	E2080-G000-303
First Posted:	July 29, 2011
Last Update Posted:	March 23, 2016
Last Verified:	February 2016

Keywords provided by Eisai Inc.:

Central Nervous System

Additional relevant MeSH terms:

Syndrome; Lennox Gastaut Syndrome; Disease; Pathologic Processes; Epilepsy	Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Anticonvulsants