Phase 3
N=13
A Study of Levetiracetam in Japanese Pediatric Patients With Generalized Tonic-clonic Seizures
Epilepsy · Generalized Tonic-clonic Seizures
Bottom Line
View on ClinicalTrials.gov: NCT01292837 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: The Percent Change From the Combined Baseline (4-week Retrospective Baseline and 4-week Prospective Baseline) in the Generalized Tonic-clonic Seizure Frequency Per Week Over the 24-week Treatment Period (Up-Titration and Evaluation Periods) — 45.47 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Levetiracetam (Drug)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- UCB Japan Co. Ltd.
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percent Change From the Combined Baseline (4-week Retrospective Baseline and 4-week Prospective Baseline) in the Generalized Tonic-clonic Seizure Frequency Per Week Over the 24-week Treatment Period (Up-Titration and Evaluation Periods) |
45.47 | — |
| SECONDARY The Percent Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Period Over the Evaluation Period |
44.93 | — |
| SECONDARY Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Treatment Period |
53.8 | — |
| SECONDARY Generalized Tonic-clonic Seizures 50 % Responder Rate During the Evaluation Period |
58.3 | — |
| SECONDARY Generalized Tonic-clonic Seizure Freedom Over the Treatment Period |
2 | — |
| SECONDARY Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period |
2 | — |
Summary
To evaluate the efficacy and safety of Levetiracetam dry syrup at doses up to 60 mg/kg/day or 3000 mg/day used as adjunctive therapy in Japanese pediatric patients aged ≥4 to <16 years with uncontrolled Generalized Tonic-Clonic (GTC) seizures despite treatment with 1 or 2 Anti-Epileptic Drugs (AEDs).
Eligibility Criteria
Inclusion Criteria
- An epileptic patient with generalized tonic-clonic seizures that are classifiable according to the International League Against Epilepsy classification of epileptic seizures (Epilepsia, 1981)
- A patient on a stable dose of 1 or 2 anti-epileptic drugs for the last 4 weeks (potassium bromide and sodium bromide for the last 12 weeks) prior to the Combined Baseline Period and during the Combined Baseline Period
Exclusion Criteria
- Presence of any sign (clinical or imaging procedures) suggesting a progressive brain lesion/disease, in particular, progressive disorder with epileptic seizures
- Diagnosis of Lennox-Gastaut Syndrome
- Confirmed focal epilepsy based on clinical signs (seizure types), with consistent electroencephalogram and magnetic resonance imaging features
- A history of convulsive or nonconvulsive status epilepticus while taking concomitant anti-epileptic drugs for the last 3 months prior to Visit 1
Data sourced from ClinicalTrials.gov (NCT01292837). 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.