Evaluation of the Efficacy and Safety of Adjunctive Zonisamide vs Replacement With Zonisamide of the Last Added Antiepileptic Drug

An open-label, randomized, multi-centre, superiority study to assess that, in patients who respond to zonisamide added as third drug after failure of a two-drug combination therapy, the triple therapy is superior to the conversion to a double therapy including zonisamide.

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Key information

Conditions

Partial Seizures Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UOC Neurofisiopatologia PO S. Salvatore, L’Aquila, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patients with localization-related epilepsy, who have added a second drug to the monotherapy, haven't obtained an adequate reduction of seizure frequency with this combination and have responded to zonisamide added as third drug for at least three months.

Inclusion criteria

Age ≥ 18 years;
Patients with non progressive localization-related epilepsy;
Patients who are able and willing to give written Informed Consent;
Current treatment with three antiepileptic drugs. The last antiepileptic drug introduced must be zonisamide;
50% or greater seizure reduction* as assessed after an at least three-month maintenance period with zonisamide.

= seizure frequency before starting zonisamide must be documented checking case histories.

Exclusion criteria

Patients contraindicated for zonisamide use (see SmPC);
Patients with renal or hepatic impairment;
Pregnant or lactating women;
Women of childbearing age who are not willing to use any contraceptive method with established efficacy.
Patients suffering from clinically significant psychiatric illness, psychological or behavioral problems which could interfere with study participation;
Patients with a history (within the last 12 months) of alcohol or drug abuse or dependency;
Patients who have been on an investigational drug or device within 30 days prior to the initiation of the present study;
Patients with a documented computed axial tomography (CAT) scan or magnetic resonance imaging (MRI) scan confirming the presence of a progressive neurological lesion within 12 months of the screening visit.

Treatment and study plan

Adjunctive Zonisamide

Drug

Patients will be gradually down-titrated from the first add-on following a drug-specific scheme decided by the investigator. Discontinued from the first add-on, patients will remain on duotherapy until the end of the study, or until the clinical situation mandates withdrawal from the study, e.g. in case of seizure worsening or adverse events.

Replacement with Zonisamide

Drug

Patients will continue to receive zonisamide as third drug

Primary outcomes

Number of Participants with Adverse Events as a Measure of Safety and Tolerability in patients who respond to zonisamide added as third drug after failure of a two-drug combination therapy

Time frame: 13 months

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Official study title

An Open-label, Randomized, Multi-centre, Superiority Study to Compare, in Patients With Partial Onset Seizures, the Efficacy and Safety of Adjunctive Zonisamide vs Replacement With Zonisamide of the Last Added Antiepileptic Drug

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2012
First posted: Jun 28, 2012
Registry last updated: Jul 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed