Open Label, Zonegran (Zonisamide) In Partial Onset Seizures
NCT ID: NCT00215592
Last Updated: 2016-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
1000 participants
INTERVENTIONAL
2005-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Zonegran
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Eisai Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Dr. Tone Bjaaland
Role: STUDY_DIRECTOR
Eisai Limited
Locations
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Universitatsklinikum fur Neurologie
Innsbruck, , Austria
Danish Epilepsy Center
Dianalund, , Denmark
The Epilepsy Clinic
Glostrup Municipality, , Denmark
Centre Hospitalier d'Annecy
Annecy, , France
CH Germon et Gauthier
Béthune, , France
Hopital Pellegrin Tripode
Bordeaux, , France
Hopital Gabriel Montpied
Clermont-Ferrand, , France
Hopital General
Dijon, , France
Hopital Victor Jousselin
Dreux, , France
Cabinet de neurologie
Gap, , France
Hopital de la Timone Adultes
Marseille, , France
Groupe hospitalier Pitie Salpetriere
Paris, , France
Hopital de Font Pre
Toulon, , France
CHU Bretonneau
Tours, , France
Universitatsklinikum Campus Virchow-Klinikum Wedding
Berlin, , Germany
Epilepsieklinik Tabor
Bernau B. Berlin, , Germany
Universitat Freiburg
Freiburg im Breisgau, , Germany
Epilepsiezentrum Kork
Kehl-Kork, , Germany
Arzneimittelforschung Leipzig GmbH
Leipzig, , Germany
Klinik die Weissenau
Revensburg, , Germany
Ospedale Riuniti di Bergamo
Bergamo, , Italy
Azienda Ospedaliero- Universitaria Policlinico di Catania
Catania, , Italy
Istituto Nazionale Neurologico Carlo Besta di Milano
Milan, , Italy
Azienda Ospedaliera San Paolo
Milan, , Italy
Universita di Parma
Parma, , Italy
Azienda Ospedaliera Bianchi-Melancrino-Morelli
Reggio Calabria, , Italy
Universita degli studi La Sapienza
Roma, , Italy
Universita degli Studi La Sapienza
Roma, , Italy
Nevrologisk avdelning, 10 etasje
Lillehammer, , Norway
Sandvika Neurologpraksis
Sandvika, , Norway
Avd. for nevrologi og klinisk nevrofysiologi
Trondheim, , Norway
University Hospital of Wales
Cardiff, , United Kingdom
University Hospital of North Staffordshire Royal Infirmary
Stoke-on-Trent, , United Kingdom
Countries
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Other Identifiers
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2005-001982-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
E2090-E044-401
Identifier Type: -
Identifier Source: org_study_id
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