Open Label, Zonegran (Zonisamide) In Partial Onset Seizures

Condition(s) targeted: Epilepsy

Intervention: Zonegran (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Eisai Limited

Official(s) and/or principal investigator(s):
Dr. Tone Bjaaland, Study Director, Affiliation: Eisai Limited

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

Official title: An Open Label Study Of Zonegran (Zonisamide) In Patients With Partial Onset Seizures

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Primary outcome: Seizure frequency, compared to baseline.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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.

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

Starting date: October 2005
Last updated: May 7, 2008