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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 is currently recruiting participants.
Verified February 2013 by Eisai Inc.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01405053
First received: July 27, 2011
Last updated: February 7, 2013
Last verified: February 2013
History of Changes
  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:

MedlinePlus related topics: Epilepsy
Drug Information available for: Rufinamide
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 ]

Estimated Enrollment: 75
Study Start Date: September 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: July 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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01405053

Contacts
Contact: Eisai Medical Services 1-888-422-4743

  Show 34 Study Locations
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

No publications provided

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: February 7, 2013
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Eisai Inc.:
Central Nervous System

Additional relevant MeSH terms:
Anticonvulsants
Mental Retardation
Spasms, Infantile
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mental Disorders Diagnosed in Childhood
 Mental Disorders
Epilepsy, Generalized
Epilepsy
Brain Diseases
Central Nervous System Diseases
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013