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
NCT ID: NCT01405053
Last Updated: 2019-08-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
37 participants
INTERVENTIONAL
2011-06-16
2015-11-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Rufinamide
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)
Any other approved AED
Any other approved Antiepileptic Drug
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)
Interventions
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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)
Any other approved Antiepileptic Drug
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 Criteria
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Inclusion Criteria
2. On a fixed and documented dose of one to three concomitant regionally approved antiepileptic drugs (AEDs) for a minimum of 4 weeks prior to randomization with an inadequate response to treatment.
3. Consistent seizure documentation (i.e., no uncertainty of the presence of seizures) during the pre-randomization phase.
Key Exclusion:
1. Familial short QT syndrome
2. Prior treatment with rufinamide within 30 days of baseline visit or discontinuation of rufinamide treatment due to safety issues related to rufinamide
1 Year
3 Years
ALL
No
Sponsors
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Eisai Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Alexis Arzimanoglou Arzimanoglou
Role: PRINCIPAL_INVESTIGATOR
Hopital Femme-Mere-Enfant Service D'Epilepsie -5eme etage 59 Boulevard Pinel Bron, France
Locations
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San Diego, California, United States
Aurora, Colorado, United States
Washington D.C., District of Columbia, United States
Gulf Breeze, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Wellington, Florida, United States
Augusta, Georgia, United States
Chicago, Illinois, United States
Lexington, Kentucky, United States
Shreveport, Louisiana, United States
Lebanon, New Hampshire, United States
Gibbsboro, New Jersey, United States
Rochester, New York, United States
Akron, Ohio, United States
Akson, Ohio, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Austin, Texas, United States
San Antonio, Texas, United States
Norfolk, Virginia, United States
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Toronto, Ontario, Canada
Saskatoon, , Canada
Bron, , France
Marseille, , France
Paris, , France
Ambelokipi Athens, , Greece
Pátrai, , Greece
Pendeli Athens, , Greece
Thessaloniki, , Greece
Mantova, MN, Italy
Calambrone, PI, Italy
Pisa, PI, Italy
Pavia, PV, Italy
Mantova, , Italy
Roma, , Italy
Salerno, , Italy
Elblag, , Poland
Gdansk, , Poland
Kielce, , Poland
Poznan, , Poland
Rzeszów, , Poland
Warsaw, , Poland
Cape Town, , South Africa
Countries
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References
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Brigo F, Jones K, Eltze C, Matricardi S. Anti-seizure medications for Lennox-Gastaut syndrome. Cochrane Database Syst Rev. 2021 Apr 7;4(4):CD003277. doi: 10.1002/14651858.CD003277.pub4.
Auvin S, Williams B, McMurray R, Kumar D, Perdomo C, Malhotra M. Novel seizure outcomes in patients with Lennox-Gastaut syndrome: Post hoc analysis of seizure-free days in rufinamide Study 303. Epilepsia Open. 2019 Mar 13;4(2):275-280. doi: 10.1002/epi4.12314. eCollection 2019 Jun.
Arzimanoglou A, Ferreira J, Satlin A, Olhaye O, Kumar D, Dhadda S, Bibbiani F. Evaluation of long-term safety, tolerability, and behavioral outcomes with adjunctive rufinamide in pediatric patients (>/=1 to <4 years old) with Lennox-Gastaut syndrome: Final results from randomized study 303. Eur J Paediatr Neurol. 2019 Jan;23(1):126-135. doi: 10.1016/j.ejpn.2018.09.010. Epub 2018 Sep 27.
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.
Other Identifiers
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E2080-G000-303
Identifier Type: -
Identifier Source: org_study_id
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