Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01405053
First received: July 27, 2011
Last updated: August 14, 2014
Last verified: August 2014
  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:


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: March 2016
Estimated Primary Completion Date: February 2016 (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
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

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: August 14, 2014
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:
Intellectual Disability
Spasms, Infantile
Syndrome
Brain Diseases
Central Nervous System Diseases
Disease
Epilepsy
Epilepsy, Generalized
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
Anticonvulsants
Central Nervous System Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014