Phase 3
Completed 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
Source: ClinicalTrials.gov NCT01405053 ↗Enrolled (actual)
37
Serious AEs
40.5%
Results posted
Aug 2019
Primary outcomePrimary: 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
◆ Published Evidence
Established
42citations · ~8 / year
Anti-seizure medications for Lennox-Gastaut syndrome.
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.
Linked Publications (4)
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Anti-seizure medications for Lennox-Gastaut syndrome.
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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.
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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.
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Novel seizure outcomes in patients with Lennox-Gastaut syndrome: Post hoc analysis of seizure-free days in rufinamide Study 303.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.