Long Term Follow up Treatment With Levetiracetam in Subjects of 4 Years and Older With Generalized Epilepsy

UCB Pharma SA217 enrolled

Overview

An open-label, follow-up study to evaluate the safety and efficacy of levetiracetam (LEV), in children (≥ 4 years old), adolescents and adults suffering from primary generalized seizures.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

217

Conditions

Generalized Epilepsy

Interventions

Levetiracetam 166 mgDRUG

* Active Substance: Levetiracetam * Pharmaceutical Form: Tablet * Concentration: 166 mg * Route of Administration: Oral use

Levetiracetam 250 mgDRUG

* Active Substance: Levetiracetam * Pharmaceutical Form: Tablet * Concentration: 250 mg * Route of Administration: Oral use

Levetiracetam 500 mgDRUG

* Active Substance: Levetiracetam * Pharmaceutical Form: Tablet * Concentration: 500 mg * Route of Administration: Oral use

Eligibility

Sex: ALLMin age: 4 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female children, adolescents and adults having completed the final visit of a previous study with levetiracetam (LEV) * Subjects who were/are suffering from primary generalized (type II) epileptic seizures * Subjects for whom the Investigator believes a reasonable benefit (efficacy or tolerability) from the long-term administration of LEV may be expected Exclusion Criteria: * Known clinically significant acute or chronic illness, for example: cardiac, renal or hepatic dysfunction, etc., which may impair reliable participation in the trial or necessitate the use of medication not allowed by protocol * Concomitant use of any drug with possible central nervous system effects unless at a stable dose * Concomitant use of any drug (other than hormonal treatment and the subject's normal anti-epileptic drugs (AEDs) that may influence the metabolism of the concomitant AED(s), except if the dose has been stable before entry in the study for sufficient length of time

Outcomes

Primary Outcomes

Number of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period

Time frame: Evaluation Period

Percentage of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period

Time frame: Evaluation Period

Secondary Outcomes

Number of subjects remaining seizure-free, for the All intent-to-treat (ITT) population, and Tonic-Clonic, Myoclonic, and Absence subpopulations since the beginning of this study N167 (Visit 1) during the Evaluation Period

Time frame: From Visit 1 to the end of the Evaluation Period

Percentage of subjects remaining seizure-free, for the All intent-to-treat (ITT) population, and Tonic-Clonic, Myoclonic, and Absence subpopulations since the beginning of this study N167 (Visit 1) during the Evaluation Period

Time frame: From Visit 1 to the end of the Evaluation Period

Reduction from N01057 or N166 Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types

Time frame: From N01057 or N166 Baseline to the Evaluation Period

Percentage reduction from N01057 or N166 Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types

Time frame: From N01057 or N166 Baseline to the Evaluation Period

Reduction from N01057 or N166 Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations

Time frame: From N01057 or N166 Baseline to the Evaluation Period

Percentage reduction from N01057 or N166 Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations

Data from ClinicalTrials.gov

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