Open Label Safety and Efficacy Study of Levetiracetam in Patients With Epilepsy

UCB Pharma251 enrolled

Overview

Community based study assessing safety and efficacy of levetiracetam in partial onset seizures. The optimal dose in daily clinical practice will be used.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

251

Conditions

Epilepsy, Partial

Interventions

LevetiracetamDRUG

* Pharmaceutical form: oral tablets * Concentration: 500 mg * Route of administration: Oral use

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects with epilepsy experiencing partial seizures, whether or not secondarily generalized. * Subjects must present between 3 and 42 partial seizures over the three months prior to protocol Visit 1. * Use of one (1), but no more than two (2) concomitant marketed antiepileptic drugs (AEDs) at the time of trial entry. Exclusion Criteria: * Subjects on vigabatrin, whose visual field has not been assessed as per recommendation of the manufacturer, i.e. every 6 months. * Presence of known pseudoseizures within the last year. * Presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors. * Uncountable seizures (clusters) or history of convulsive status epilepticus within the last five years.

Locations (29)

N01036 808

Hong Kong, Hong Kong

N01036 842

Hong Kong, Hong Kong

Outcomes

Primary Outcomes

Number of Patients With Adverse Events (AEs)

An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.

Time frame: From Baseline until Safety visit (two weeks after last dose; up to Week 18)

Secondary Outcomes

Percentage Change From Historical Baseline in Partial (Type I) Seizure Frequency Per Week Over the Treatment Period

Percentage change from baseline in partial (Type I) seizure frequency over the treatment period standardized to 1 week period. Type I Partial (focal, local) seizure frequency per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 1 week period. A negative value in percent change from historical baseline indicates a decrease in partial (type I) seizure frequency from historical baseline.

Time frame: Week 16, compared to Baseline

Percentage Change From Historical Baseline in Total (Type I+II+III) Seizure Frequency Per Week Over the Treatment Period

Percentage change from baseline in total (type I+II+III) seizure frequency over the treatment period standardized to 1 week period. Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or non-convulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 1 week period. A negative value in percent change from historical baseline indicates a decrease in total (type I+II+III) seizure frequency from historical baseline.

Time frame: Week 16, compared to Baseline

Percentage of Participants With 50% Response in Seizure Frequency Per Week at Week 16

50% response in seizure frequency per Week is defined as \>=50% reduction in seizure frequency from Baseline. Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or non-convulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 1 week period.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.