Phase 3
Completed N=73
An Open Label Study of Levetiracetam in Japanese Pediatric Patients With Partial Seizures
Epilepsy · Partial Seizures
Source: ClinicalTrials.gov NCT01063764 ↗
Enrolled (actual)
73
Serious AEs
11.0%
Results posted
Jun 2012
Primary outcomePrimary: Change From Baseline in Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period — 43.21 Percent reduction
Summary
Objective of the First Period: To evaluate the efficacy of Levetiracetam dry syrup at doses up to a maximum of 60 mg/kg/day or 3000 mg/day used as an adjunctive therapy in Japanese pediatric patients (4 to 16 years) with uncontrolled partial seizures despite treatment with 1 or 2 anti-epileptic drug(s).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period |
43.21 | — |
| PRIMARY Incidence of Treatment-Emergent Adverse Events (TEAEs) During the Second Period (up to Three Years Until the Time of Approval Granted) |
98.2 | — |
| SECONDARY Change From Baseline in Partial Seizure Frequency Per Week Over the 10-week Evaluation Period |
39.02 | — |
| SECONDARY Partial Seizure Frequency Per Week Over the 14-weeks Treatment Period |
3.92 | — |
| SECONDARY Partial Seizure Frequency Per Week Over the 10-weeks Evaluation Period |
3.90 | — |
| SECONDARY Percentage of Partial Seizures 50 % Responders Over the 14-weeks Treatment Period |
38.4 | — |
| SECONDARY Percentage of Partial Seizures 50 % Responders Over the 10-weeks Evaluation Period |
38.2 | — |
| SECONDARY Number of Seizure-free Subjects Over the 14-weeks Treatment Period |
2 | — |
| SECONDARY Number of Seizure-free Subjects Over the 10-weeks Evaluation Period |
3 | — |
| SECONDARY Incidence of Treatment-emergent Adverse Drug Reactions (ADRs) During the Second Period (up to Three Years Until the Time of Approval Granted) |
15 | — |
| SECONDARY Change From Baseline in Partial Seizure Frequency Per Week for the Second Period (up to Three Years From Informed Consent Until the Time of Approval Granted) |
41.32 | — |
Eligibility Criteria
Inclusion Criteria
- The patient has partial Epilepsy and the diagnosis must be confirmed in the last 6 months
- The patients must be on a stable 1 or 2 anti-epileptic drug(s) treatment during the 4 weeks prior to Baseline and must have at least 8 partial seizures during the 8-week prospective Baseline Period
- Patient at the age of 4 to 16 years, and at the body weight of 11 to 82 kg
Exclusion Criteria
- The patient has a treatable seizure etiology
- The patient has Epilepsy secondary to a progressive cerebral disease or any other progressively neurodegenerative disease, including Rasmussen and Landau-Kleffner diseases
- The patient has a history of status Epilepticus during the 3 months prior to Visit 1
- The patient has a past and present history of pseudo seizures
- The patient has a current diagnosis of Lennox-Gastaut syndrome
Data sourced from ClinicalTrials.gov (NCT01063764). 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.