To determine the efficacy and safety of adjunctive open label Zonegran treatment in patients
with refractory partial seizures.
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.
Universitatsklinikum fur Neurologie, Innsbruck 6020, Austria
Danish Epilepsy Center, Dianalund 4293, Denmark
The Epilepsy Clinic, Glostrup 2600, Denmark
Hopital Gabriel Montpied, Clermont-Ferrand Cedex 1 63003, France
CHU Bretonneau, Tours Cedex 37044, France
Centre Hospitalier d'Annecy, Annecy cedex 74011, France
Hopital de Font Pre, Toulon cedex 83056, France
Cabinet de neurologie, Gap 05000, France
Hopital Pellegrin Tripode, Bordeaux cedex 33076, France
Groupe hospitalier Pitie Salpetriere, Paris 75651, France
Hopital General, Dijon 21033, France
Hopital Victor Jousselin, Dreux 28102, France
CH Germon et Gauthier, Bethune 62408, France
Hopital de la Timone Adultes, Marseille 13385, France
Universitat Freiburg, Freiburg 79106, Germany
Epilepsiezentrum Kork, Kehl-Kork 77694, Germany
Arzneimittelforschung Leipzig GmbH, Leipzig 04107, Germany
Epilepsieklinik Tabor, Bernau b. Berlin 16321, Germany
Universitatsklinikum Campus Virchow-Klinikum Wedding, Berlin 13353, Germany
Klinik die Weissenau, Revensburg 88214, Germany
Azienda Ospedaliera Bianchi-Melancrino-Morelli, Reggio Calabria 89100, Italy
Istituto Nazionale Neurologico Carlo Besta di Milano, Milano 20133, Italy
Azienda Ospedaliero- Universitaria Policlinico di Catania, Catania 95125, Italy
Ospedale Riuniti di Bergamo, Bergamo 24128, Italy
Universita degli Studi La Sapienza, Roma 00185, Italy
Azienda Ospedaliera San Paolo, Milano 20142, Italy
Universita di Parma, Parma 43100, Italy
Universita degli studi La Sapienza, Roma 00161, Italy
Sandvika Neurologpraksis, Sandvika 1338, Norway
Nevrologisk avdelning, 10 etasje, Lillehammer 2609, Norway
Avd. for nevrologi og klinisk nevrofysiologi, Trondheim 7006, Norway
University Hospital of North Staffordshire Royal Infirmary, Stoke On Trent ST4 7LN, United Kingdom
University Hospital of Wales, Cardiff CF14 4XW, United Kingdom
