Phase 3
N=37
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
Lennox-Gastaut Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01405053 ↗Enrolled (actual)
37
Serious AEs
40.5%
Results posted
Aug 2019
Primary outcome: Primary: Child Behavior Checklist (CBCL) Total Problem T-scores at the End of 2-year Treatment Period — 55.7; 54.8 score on a scale — p=0.6928
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rufinamide (Drug); Any other approved Antiepileptic Drug (Drug)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- Eisai Inc.
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Child Behavior Checklist (CBCL) Total Problem T-scores at the End of 2-year Treatment Period |
55.7; 54.8 | 0.6928 |
| PRIMARY Change From Baseline in CBCL Total Problem T-Scores at End of 2-year Treatment Period |
56.6; 62.8; -0.3; -6.7 | — |
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 taking other anti-epileptic drugs.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01405053). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.