A Study to Evaluate the Efficacy and Safety of Seletracetam in Adult Patients With Refractory Partial Onset Seizures

UCB Pharma

Overview

This study will evaluate the effectiveness and safety of seletracetam when it is used in addition to other anti-epileptic medications by patients with partial onset seizures. It will also help to determine the best dose to use.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Epilepsies, Partial

Interventions

SeletracetamDRUG

Eligibility

Sex: ALLMin age: 16 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects from 16 to 70 years old * Confirmed diagnosis of focal epilepsy * Partial seizures uncontrolled while taking 1 or 2 AEDs * At least 8 partial seizures during the 8-week baseline period Exclusion Criteria: * Seizures occurring only in clusters * Status epilepticus within 1 year * Progressive CNS disorder * Other serious or uncontrolled diseases

Outcomes

Primary Outcomes

Evaluate the efficacy of seletracetam compared to placebo in reducing seizure frequency in subjects with partial onset seizures not fully controlled despite treatment with 1 - 2 concomittant AEDs

Secondary Outcomes

Explore the dose/clinical response relation; safety and tolerability; effects of treatment on patients' Health-Related Quality of Life (HRQoL)

Data from ClinicalTrials.gov

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