Clinical trial NCT00215592: Open Label, Zonegran (Zonisamide) In Partial Onset Seizures
Official title: An Open Label Study Of Zonegran (Zonisamide) In Patients With Partial Onset Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epilepsy
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the efficacy and safety of adjunctive open label Zonegran treatment in patients with refractory partial seizures.


Eligibility criteria: Inclusion Criteria:

1. Male or female patients aged 18-75.
2. Able and willing to give written informed consent in accordance with the ICH GCP Guidelines.
3. Female subjects of childbearing potential must not be pregnant (as confirmed by negative serum βHCG at screening and negative urine pregnancy test at baseline/during the study), must not be lactating and must use a medically acceptable form of contraception during the study and for at least 1 month after discontinuation of study drug. Medically acceptable contraception as defined here is the oral contraceptive pill, surgical sterilization or hormonal intrauterine device in place for at least 3 months. Women who are less than 2 years post-menopausal are considered to be of childbearing potential.
4. Focal epilepsy, with simple and/or complex partial seizures with or without secondary generalized seizures as defined by the ILAE criteria.
5. Patients with a minimum of 4 partial seizures in the 8 weeks preceding the baseline visit as adequately recorded using a seizure diary card.
6. Patients should be receiving at least 1 but no more than 2 other AEDs as concomitant medication, and the dosage should be stable for at least 8 weeks before the baseline visit.

Exclusion Criteria:

1. History of status epilepticus within the last 5 years.
2. Patients with known significantly impaired renal function and/or severe hepatic impairment to the extent that the protocol dose titration schedule cannot be followed. Note Investigators should consult included SmPC as a guide.
3. Patients suffering from clinically significant psychiatric illness, psychological or behavioral problems which could interfere with study participation.
4. Patients with a history (within the last 12 months) of alcohol or drug abuse or dependency.
5. Patient suffering from any CNS progressive disease that may confound study interpretation, any active CNS infection, demyelinating disease or degenerative neurological disease.
6. Patients with a significant drug sensitivity or significant allergic reaction to any drug including sulfonamides.
7. Subjects considered by the Investigator to be an unsuitable candidate for receiving Zonegran or considered unlikely to comply with the protocol.
8. Any patient contraindicated for Zonegran treatment as per attached SmPC.
9. Any patient who is pregnant and/or lactating.

Primary outcomes:
measure: Seizure frequency, compared to baseline.
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Universitatsklinikum fur Neurologie
city: Dianalund
country: Denmark
facility: Danish Epilepsy Center
city: Glostrup
country: Denmark
facility: The Epilepsy Clinic
city: Annecy cedex
country: France
facility: Centre Hospitalier d'Annecy
city: Bethune
country: France
facility: CH Germon et Gauthier
city: Bordeaux cedex
country: France
facility: Hopital Pellegrin Tripode
city: Clermont-Ferrand Cedex 1
country: France
facility: Hopital Gabriel Montpied
city: Dijon
country: France
facility: Hopital General
city: Dreux
country: France
facility: Hopital Victor Jousselin
city: Gap
country: France
facility: Cabinet de neurologie
city: Marseille
country: France
facility: Hopital de la Timone Adultes
city: Paris
country: France
facility: Groupe hospitalier Pitie Salpetriere
city: Toulon cedex
country: France
facility: Hopital de Font Pre
city: Tours Cedex
country: France
facility: CHU Bretonneau
city: Berlin
country: Germany
facility: Universitatsklinikum Campus Virchow-Klinikum Wedding
city: Bernau b. Berlin
country: Germany
facility: Epilepsieklinik Tabor
city: Freiburg
country: Germany
facility: Universitat Freiburg
city: Kehl-Kork
country: Germany
facility: Epilepsiezentrum Kork
city: Leipzig
country: Germany
facility: Arzneimittelforschung Leipzig GmbH
city: Revensburg
country: Germany
facility: Klinik die Weissenau
city: Bergamo
country: Italy
facility: Ospedale Riuniti di Bergamo
city: Catania
country: Italy
facility: Azienda Ospedaliero- Universitaria Policlinico di Catania
city: Milano
country: Italy
facility: Istituto Nazionale Neurologico Carlo Besta di Milano
city: Milano
country: Italy
facility: Azienda Ospedaliera San Paolo
city: Parma
country: Italy
facility: Universita di Parma
city: Reggio Calabria
country: Italy
facility: Azienda Ospedaliera Bianchi-Melancrino-Morelli
city: Roma
country: Italy
facility: Universita degli studi La Sapienza
city: Roma
country: Italy
facility: Universita degli Studi La Sapienza
city: Lillehammer
country: Norway
facility: Nevrologisk avdelning, 10 etasje
city: Sandvika
country: Norway
facility: Sandvika Neurologpraksis
city: Trondheim
country: Norway
facility: Avd. for nevrologi og klinisk nevrofysiologi
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: Stoke On Trent
country: United Kingdom
facility: University Hospital of North Staffordshire Royal Infirmary
Study officials:
affiliation: Eisai Limited
name: Dr. Tone Bjaaland
role: STUDY_DIRECTOR
References: