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 - Full Text View

Purpose

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 Endpoint Classification: Safety/Efficacy Study 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:

Genetics Home Reference related topics: Lennox-Gastaut syndrome pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy

Drug Information available for: Rufinamide

Genetic and Rare Diseases Information Center resources: Lennox-Gastaut Syndrome

U.S. FDA Resources

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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to withdrawal from rufinamide or other AED [ Time Frame: Baseline to the end of the Treatment Period (=106 weeks) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
Worsening of seizures [ Time Frame: Baseline to the end of the Treatment Period (=106 weeks) ] [ Designated as safety issue: No ]
Change in CBCL subscores [ Time Frame: Baseline to the end of the Treatment Period (=106 weeks) ] [ Designated as safety issue: No ]
Change in Language Development Survey score during Maintenance Period [ Time Frame: Baseline to the end of the Treatment Period (=106 weeks) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]


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)

Eligibility


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

Criteria

Key Inclusion:

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).
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.
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:

Familial short QT syndrome
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 ClinicalTrials.gov identifier: NCT01405053

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

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
Study First Received:	July 27, 2011
Last Updated:	March 21, 2016
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 26, 2016