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Open Label, Zonegran (Zonisamide) In Partial Onset Seizures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00215592
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : January 8, 2016
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Limited )

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

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Zonegran Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1000 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study Of Zonegran (Zonisamide) In Patients With Partial Onset Seizures
Study Start Date : October 2005
Actual Primary Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures
Drug Information available for: Zonisamide

Primary Outcome Measures :
  1. Seizure frequency, compared to baseline.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00215592

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

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Responsible Party: Eisai Limited Identifier: NCT00215592     History of Changes
Other Study ID Numbers: E2090-E044-401
2005-001982-33 ( EudraCT Number )
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: January 8, 2016
Last Verified: November 2015
Additional relevant MeSH terms:
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Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs