A Double-blind, Phase III, Multicenter, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Levetiracetam as Adjunctive Therapy, in Partial Seizures Control Associated With Refractory Focal Epilepsy

Ache Laboratorios Farmaceuticos S.A.0 sites126 target enrollmentJanuary 2013

ConditionsEpilepsy Partial Seizures

InterventionsLevetiracetam Placebo

DrugsLevetiracetam Placebo

Overview

Phase: Phase 3
Intervention: Levetiracetam
Conditions: Epilepsy
Sponsor: Ache Laboratorios Farmaceuticos S.A.
Enrollment: 126
Primary Endpoint: Partial onset seizure frequency per week.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to determine whether levetiracetam as adjunctive therapy is effective in the treatment of partial seizures, with or without secondary generalization, associated with refractory focal epilepsy.

Registry

clinicaltrials.gov

Start Date

January 2013

End Date

August 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ache Laboratorios Farmaceuticos S.A.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients of both sexes, aged between 04 and 65 years, remaining the feasibility of a legal guardian in accordance with need, able to understand and provide written informed consent and able to allow compliance at the treatment and the requirements of the protocol;
•Patient´s weight ≥ 20kg;
•Consistent diagnosis of refractory focal epilepsy, with or without secondary generalization;
•Patient with onset of seizures for at least 02 years preceding the screening visit;
•Presence at least 12 partial seizures during the 03 months preceding the screening visit (04 seizures per month);
•Only seizures that generate motor manifestation will be recorded in this study.
•Absence of brain injury progressive or expansive, previously documented by CT scan, MRI or other imaging test applicable (in the last 05 years;
•Patient with electroencephalogram performed up to 02 years before this visit;
•Subject with stable regimen (minimum of 01 month) from one to three antiepileptic drugs.
•Vagus nerve stimulation for 04 weeks prior to V1, or use of benzodiazepines for more than 07 consecutive days will be considered as concomitant epileptic drugs)

Exclusion Criteria

•Patients with:
•Seizures of non epileptic origin;
•Pseudoseizures;
•Seizures occurring in clustered patterns (03 or more seizures in 30 minutes), in the 03 months preceding the screening visit (V1);
•History of status epilepticus while taking antiepileptic drugs during the 03 months that preceding the screening visit (V1).
•Epileptic syndromes that occurs with cognitive deficits or secondary epilepsy evolving from some brain disease;
•History of schizophrenia or suicide attempt;
•Patients with psychiatric ill ongoing;
•Presence of severe mental retardation of any etiology;
•Previous exposure to levetiracetam;

Arms & Interventions

Levetiracetam

Intervention: Levetiracetam

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Partial onset seizure frequency per week.

Time Frame: From baseline to week 24

Collection of seizure count throughout the whole study

Secondary Outcomes

Proportions of response between the groups of treatment. (Responders defined as number of patients with at least 50% reduction in the number of weekly partial seizures)(From baseline to week 24)
Safety descriptive about occurence of adverse events, evaluation of results of clinical/physical examination and ECG and laboratory tests results.(From baseline to week 30)
Percentage reduction from baseline in partial seizure frequency of days a week.(From baseline to week 24)
Proportion of response between the groups of treatment. (Responders defined as number of subjects with at least 50% reduction in the number of days per week with partial seizures)(From baseline to week 24)
Proportion between the groups of treatment without any kind of seizures. (seizure free)(12 weeks after the titration period (period with stable regimen of the drug))