Open Label, Zonegran (Zonisamide) In Partial Onset Seizures

January 6, 2016 updated by: Eisai Limited

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Seizure frequency, compared to baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Limited

Investigators

  • Study Director: Dr. Tone Bjaaland, Eisai Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

January 8, 2016

Last Update Submitted That Met QC Criteria

January 6, 2016

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2090-E044-401
  • 2005-001982-33 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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