Clinical trial NCT01630057: Evaluation of the Efficacy and Safety of Adjunctive Zonisamide vs Replacement With Zonisamide of the Last Added Antiepileptic Drug
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Partial Seizures
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2012-06-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: 13 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: AOU Ospedali riuniti Umberto I -G.M Lancisi-G.Salesi
city: Bari
country: Italy
facility: AO Universitaria Consorziale Policlinico di Bari
city: Bosisio Parini
country: Italy
facility: Irccs "E. Medea"
city: Cagliari
country: Italy
facility: Struttura di Neurofisiopatologia, Universit? degli studi di Cagliari
city: Conegliano
country: Italy
facility: IRCCS "Eugenio Medea" Polo Scientifico di Conegliano
city: Ferrara
country: Italy
facility: AOU di Ferrara Arcispedale S. Anna
city: Gallarate
country: Italy
facility: Presidio Ospedale "S.Antonio Abate di Gallarate"
city: L'Aquila
country: Italy
facility: UOC Neurofisiopatologia PO S. Salvatore
city: Lodi
country: Italy
facility: AO della Provincia di Lodi
city: Messina
country: Italy
facility: IRCCS Centro neurolesi "Bonino Pulejo" di Messina
city: Napoli
country: Italy
facility: AO di Rilievo Nazionale Antonio Cardarelli
city: Napoli
country: Italy
facility: AO Universitaria Federico II
city: Palermo
country: Italy
facility: AO Universitaria Policlinico Paolo Giaccone dell'Universit? degli Studi di Palermo
city: Pisa
country: Italy
facility: AO Universitaria -Pisana
city: Potenza
country: Italy
facility: AO Regionale "San Carlo" di Potenza
city: Prato
country: Italy
facility: PO "Misericordia e dolce"-USL 4 di Prato
city: Roma
country: Italy
facility: Azienda Complesso Ospedaliero San Filippo Neri
city: Roma
country: Italy
facility: Umberto I Policlinico di Roma
city: Venezia
country: Italy
facility: Ospedale SS Giovanni e Paolo Azienda ULSS 12 Veneziana
Study officials:
affiliation: Federico II University
name: Salvatore Striano
role: PRINCIPAL_INVESTIGATOR
References: