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
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ClinicalTrials.gov Identifier: NCT01405053 |
Recruitment Status
:
Completed
First Posted
: July 29, 2011
Last Update Posted
: March 23, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lennox-Gastaut Syndrome | Drug: Rufinamide Drug: Any other approved AED | Phase 3 |
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 |

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)
|
- Change in Child Behavior Checklist (CBCL) Total Problems Score [ Time Frame: Baseline to the end of the Treatment Period (=106 weeks) ]
- Time to withdrawal from rufinamide or other AED [ Time Frame: Baseline to the end of the Treatment Period (=106 weeks) ]
- 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) ]
- Worsening of seizures [ Time Frame: Baseline to the end of the Treatment Period (=106 weeks) ]
- Change in CBCL subscores [ Time Frame: Baseline to the end of the Treatment Period (=106 weeks) ]
- Change in Language Development Survey score during Maintenance Period [ Time Frame: Baseline to the end of the Treatment Period (=106 weeks) ]
- 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) ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01405053
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 |
Principal Investigator: | Alexis Arzimanoglou Arzimanoglou | Hopital Femme-Mere-Enfant Service D'Epilepsie -5eme etage 59 Boulevard Pinel Bron, France |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Eisai Inc. |
ClinicalTrials.gov Identifier: | NCT01405053 History of Changes |
Other Study ID Numbers: |
E2080-G000-303 |
First Posted: | July 29, 2011 Key Record Dates |
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 |