Status:
COMPLETED
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
Lead Sponsor:
Eisai Inc.
Conditions:
Lennox-Gastaut Syndrome
Eligibility:
All Genders
1-3 years
Phase:
PHASE3
Brief Summary
This study was designed to evaluate the cognitive effect, safety, and pharmacokinetics (PK) of rufinamide on Lennox-Gastaut Syndrome (LGS) inadequately controlled in pediatric participants already tak...
Eligibility Criteria
Inclusion
- Key Inclusion:
- Clinical diagnosis of LGS, 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, atypical benign partial epilepsy (pseudo-Lennox syndrome), or continuous spike-waves of slow sleep (CSWS).
- 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.
- Consistent seizure documentation (i.e., no uncertainty of the presence of seizures) during the pre-randomization phase.
- Key Exclusion:
- Familial short QT syndrome
- Prior treatment with rufinamide within 30 days of baseline visit or discontinuation of rufinamide treatment due to safety issues related to rufinamide
Exclusion
Key Trial Info
Start Date :
June 16 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2015
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01405053
Start Date
June 16 2011
End Date
November 2 2015
Last Update
August 6 2019
Active Locations (47)
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1
San Diego, California, United States, 92123
2
Aurora, Colorado, United States, 80045
3
Washington D.C., District of Columbia, United States, 20010
4
Gulf Breeze, Florida, United States, 32561