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 Compare, in Patients With Partial Onset Seizures, the Efficacy and Safety of Adjunctive Zonisamide vs Replacement With Zonisamide of the Last Added Antiepileptic Drug

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01630057

Enrollment

200

Registered

2012-06-28

Start date

2009-09-30

Completion date

2012-07-31

Last updated

2014-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Partial Seizures

Brief summary

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.

Interventions

DRUGAdjunctive Zonisamide

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.

DRUGReplacement with Zonisamide

Patients will continue to receive zonisamide as third drug

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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	13 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026