Efficacy and Tolerability of Levetiracetam Add-On Treatment in Refractory Pediatric Patients With Partial Onset Seizures

UCB Pharma216 enrolled

Overview

Double-blind, randomized, placebo-controlled, multi-center clinical trial conducted to evaluate levetiracetam as adjunctive therapy in children (4-16 years) with refractory partial onset seizures.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

216

Conditions

Epilepsy

Interventions

LevetiracetamDRUG

* high total tablet weight (HTTW) formulation in tablet strengths of 166.5 mg, 250 mg, and 500 mg was used for patients weighing at least 40.1 kg * low total tablet weight (LTTW) formulation in tablet strengths of 166 mg and 250 mg was used for patients weighing 40 kg or less

PlaceboDRUG

Placebo tablets for oral administration that were identical in appearance to the respective formulations (LTTW and HTTW) were used as reference therapy

Eligibility

Sex: ALLMin age: 4 YearsMax age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * diagnosis of epilepsy with uncontrolled partial onset seizures, whether or not secondarily generalized, and the diagnosis was \>= 6 months before the Selection Visit * epilepsy was classifiable according to the ILAE Classification * \>= 4 partial onset seizures during the 4 weeks preceding the Selection Visit and were required to have \>= 4 partial onset seizures during each 4-week interval of the Baseline Period to qualify for randomization * unsatisfactory current AED treatment in terms of efficacy and/or safety * stable AED treatment consisting of no more than two AEDs Exclusion Criteria: * treatable seizure etiology * epilepsy secondary to a progressive cerebral disease or any other progressively neurodegenerative disease, including Rasmussen and Landau-Kleffner diseases * history of status epilepticus which required hospitalization during 3 months prior to the Selection Visit * history of or the presence of pseudo seizures * current diagnosis of Lennox-Gastaut syndrome

Outcomes

Primary Outcomes

Partial onset seizure frequency (Type I, Type IC included) per week during the Treatment period

Calculated as 7-day partial onset seizure frequency.

Time frame: During the 14-weeks Treatment period (Week 8 to Week 22)

Secondary Outcomes

50% responder rate in seizure frequency per week during the Treatment Period

Response rate is defined as percent of patients experiencing at least a 50% reduction from baseline in the seizure frequency per week during the Treatment Period.

Time frame: During the 14-weeks Treatment period (Week 8 to Week 22)

Percent of patients with categorized reduction from baseline in seizure frequency per week during the Treatment Period

Categories as follows: \<-25%, -25% to \<25%, 25% to \<50%, 50% to \<75%, 75% to \<100%, and 100%

Time frame: From Baseline to the 14-weeks Treatment period

Change from baseline in the average duration of seizure free intervals

Intervals are defined as seizure-free if no seizures are reported.

Time frame: From Baseline to the 14-weeks Treatment period

Number of seizure free days during the Treatment Period

A day is regarded as seizure-free if no seizures are reported.

Time frame: During the 14-weeks Treatment period (Week 8 to Week 22)

Absolute change from baseline in partial onset seizure frequency per week during the Treatment Period

Absolute change from baseline in partial onset seizure frequency during the Treatment Period standardized to 1 week period. A negative value in absolute change from baseline indicates a decrease in partial onset seizure frequency from baseline.

Data from ClinicalTrials.gov

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Time frame: Baseline, During the 14-weeks Treatment period (Week 8 to Week 22)

Absolute change from baseline in partial onset seizure frequency per week during the Titration Period

Absolute change from baseline in partial onset seizure frequency during the Titration Period standardized to 1 week period. A negative value in absolute change from baseline indicates a decrease in partial onset seizure frequency from baseline.

Time frame: Baseline, During the 6-weeks Titration period (Week 8 to Week 14)

Absolute change from baseline in partial onset seizure frequency per week during the Evaluation Period

Absolute change from baseline in partial onset seizure frequency during the Evaluation Period standardized to 1 week period. A negative value in absolute change from baseline indicates a decrease in partial onset seizure frequency from baseline.

Time frame: Baseline, During the 8-weeks Evaluation period (Week 14 to Week 22)

Percent change from baseline in partial onset seizure frequency per week during the Treatment Period

Percent change from baseline in partial onset seizure frequency during the Treatment Period standardized to 1 week period. A negative value in absolute change from baseline indicates a decrease in partial onset seizure frequency from baseline.

Time frame: Baseline, During the 14-weeks Treatment period (Week 8 to Week 22)

Percent change from baseline in partial onset seizure frequency per week during the Titration Period

Percent change from baseline in partial onset seizure frequency during the Titration Period standardized to 1 week period. A negative value in absolute change from baseline indicates a decrease in partial onset seizure frequency from baseline.

Time frame: Baseline, During the 6-weeks Titration period (Week 8 to Week 14)

Percent change from baseline in partial onset seizure frequency per week during the Evaluation Period

Percent change from baseline in partial onset seizure frequency during the Evaluation Period standardized to 1 week period. A negative value in absolute change from baseline indicates a decrease in partial onset seizure frequency from baseline.

Time frame: Baseline, During the 8-weeks Evaluation period (Week 14 to Week 22)

Cumulative percentage of patients who were seizure-free since the beginning of the Evaluation Period

A subject was regarded as seizure-free if not seizures were reported since the beginning of the Evaluation Period.

Time frame: Beginning of the Evaluation Period (Week 14)

Partial onset seizure frequency per week during the Titration Period

Calculated as 7-day partial onset seizure frequency.

Time frame: During the 6-weeks Titration period (Week 8 to Week 14)

Partial onset seizure frequency per week during the Evaluation Period

Calculated as 7-day partial onset seizure frequency.

Time frame: During the 6-weeks Evaluation period (Week 8 to Week 14)

Total seizure frequency per week (Types I + II + III) during the Treatment Period

Calculated as 7-day partial onset seizure frequency.

Time frame: During the 14-weeks Treatment period (Week 8 to Week 22)

Total seizure frequency per week (Types I + II + III) during the Titration Period

Calculated as 7-day partial onset seizure frequency.

Time frame: During the 6-weeks Titration period (Week 8 to Week 14)

Total seizure frequency per week (Types I + II + III) during the Evaluation Period

Calculated as 7-day partial onset seizure frequency.

Time frame: During the 6-weeks Evaluation period (Week 8 to Week 14)