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Open Label, Zonegran (Zonisamide) In Partial Onset Seizures

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Zonegran
Sponsored by
Eisai Limited
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female patients aged 18-75. Able and willing to give written informed consent in accordance with the ICH GCP Guidelines. 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. Focal epilepsy, with simple and/or complex partial seizures with or without secondary generalized seizures as defined by the ILAE criteria. Patients with a minimum of 4 partial seizures in the 8 weeks preceding the baseline visit as adequately recorded using a seizure diary card. 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: History of status epilepticus within the last 5 years. 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. Patients suffering from clinically significant psychiatric illness, psychological or behavioral problems which could interfere with study participation. Patients with a history (within the last 12 months) of alcohol or drug abuse or dependency. Patient suffering from any CNS progressive disease that may confound study interpretation, any active CNS infection, demyelinating disease or degenerative neurological disease. Patients with a significant drug sensitivity or significant allergic reaction to any drug including sulfonamides. Subjects considered by the Investigator to be an unsuitable candidate for receiving Zonegran or considered unlikely to comply with the protocol. Any patient contraindicated for Zonegran treatment as per attached SmPC. Any patient who is pregnant and/or lactating.

Sites / Locations

  • Universitatsklinikum fur Neurologie
  • Danish Epilepsy Center
  • The Epilepsy Clinic
  • Centre Hospitalier d'Annecy
  • CH Germon et Gauthier
  • Hopital Pellegrin Tripode
  • Hopital Gabriel Montpied
  • Hopital General
  • Hopital Victor Jousselin
  • Cabinet de neurologie
  • Hopital de la Timone Adultes
  • Groupe hospitalier Pitie Salpetriere
  • Hopital de Font Pre
  • CHU Bretonneau
  • Universitatsklinikum Campus Virchow-Klinikum Wedding
  • Epilepsieklinik Tabor
  • Universitat Freiburg
  • Epilepsiezentrum Kork
  • Arzneimittelforschung Leipzig GmbH
  • Klinik die Weissenau
  • Ospedale Riuniti di Bergamo
  • Azienda Ospedaliero- Universitaria Policlinico di Catania
  • Istituto Nazionale Neurologico Carlo Besta di Milano
  • Azienda Ospedaliera San Paolo
  • Universita di Parma
  • Azienda Ospedaliera Bianchi-Melancrino-Morelli
  • Universita degli studi La Sapienza
  • Universita degli Studi La Sapienza
  • Nevrologisk avdelning, 10 etasje
  • Sandvika Neurologpraksis
  • Avd. for nevrologi og klinisk nevrofysiologi
  • University Hospital of Wales
  • University Hospital of North Staffordshire Royal Infirmary

Outcomes

Primary Outcome Measures

Seizure frequency, compared to baseline.

Secondary Outcome Measures

Full Information

First Posted
September 14, 2005
Last Updated
January 6, 2016
Sponsor
Eisai Limited
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1. Study Identification

Unique Protocol Identification Number
NCT00215592
Brief Title
Open Label, Zonegran (Zonisamide) In Partial Onset Seizures
Official Title
An Open Label Study Of Zonegran (Zonisamide) In Patients With Partial Onset Seizures
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Limited

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1000 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zonegran
Primary Outcome Measure Information:
Title
Seizure frequency, compared to baseline.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients aged 18-75. Able and willing to give written informed consent in accordance with the ICH GCP Guidelines. 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. Focal epilepsy, with simple and/or complex partial seizures with or without secondary generalized seizures as defined by the ILAE criteria. Patients with a minimum of 4 partial seizures in the 8 weeks preceding the baseline visit as adequately recorded using a seizure diary card. 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: History of status epilepticus within the last 5 years. 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. Patients suffering from clinically significant psychiatric illness, psychological or behavioral problems which could interfere with study participation. Patients with a history (within the last 12 months) of alcohol or drug abuse or dependency. Patient suffering from any CNS progressive disease that may confound study interpretation, any active CNS infection, demyelinating disease or degenerative neurological disease. Patients with a significant drug sensitivity or significant allergic reaction to any drug including sulfonamides. Subjects considered by the Investigator to be an unsuitable candidate for receiving Zonegran or considered unlikely to comply with the protocol. Any patient contraindicated for Zonegran treatment as per attached SmPC. Any patient who is pregnant and/or lactating.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Tone Bjaaland
Organizational Affiliation
Eisai Limited
Official's Role
Study Director
Facility Information:
Facility Name
Universitatsklinikum fur Neurologie
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Danish Epilepsy Center
City
Dianalund
ZIP/Postal Code
4293
Country
Denmark
Facility Name
The Epilepsy Clinic
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Centre Hospitalier d'Annecy
City
Annecy cedex
ZIP/Postal Code
74011
Country
France
Facility Name
CH Germon et Gauthier
City
Bethune
ZIP/Postal Code
62408
Country
France
Facility Name
Hopital Pellegrin Tripode
City
Bordeaux cedex
ZIP/Postal Code
33076
Country
France
Facility Name
Hopital Gabriel Montpied
City
Clermont-Ferrand Cedex 1
ZIP/Postal Code
63003
Country
France
Facility Name
Hopital General
City
Dijon
ZIP/Postal Code
21033
Country
France
Facility Name
Hopital Victor Jousselin
City
Dreux
ZIP/Postal Code
28102
Country
France
Facility Name
Cabinet de neurologie
City
Gap
ZIP/Postal Code
05000
Country
France
Facility Name
Hopital de la Timone Adultes
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Groupe hospitalier Pitie Salpetriere
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Hopital de Font Pre
City
Toulon cedex
ZIP/Postal Code
83056
Country
France
Facility Name
CHU Bretonneau
City
Tours Cedex
ZIP/Postal Code
37044
Country
France
Facility Name
Universitatsklinikum Campus Virchow-Klinikum Wedding
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Epilepsieklinik Tabor
City
Bernau b. Berlin
ZIP/Postal Code
16321
Country
Germany
Facility Name
Universitat Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Epilepsiezentrum Kork
City
Kehl-Kork
ZIP/Postal Code
77694
Country
Germany
Facility Name
Arzneimittelforschung Leipzig GmbH
City
Leipzig
ZIP/Postal Code
04107
Country
Germany
Facility Name
Klinik die Weissenau
City
Revensburg
ZIP/Postal Code
88214
Country
Germany
Facility Name
Ospedale Riuniti di Bergamo
City
Bergamo
ZIP/Postal Code
24128
Country
Italy
Facility Name
Azienda Ospedaliero- Universitaria Policlinico di Catania
City
Catania
ZIP/Postal Code
95125
Country
Italy
Facility Name
Istituto Nazionale Neurologico Carlo Besta di Milano
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Azienda Ospedaliera San Paolo
City
Milano
ZIP/Postal Code
20142
Country
Italy
Facility Name
Universita di Parma
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Azienda Ospedaliera Bianchi-Melancrino-Morelli
City
Reggio Calabria
ZIP/Postal Code
89100
Country
Italy
Facility Name
Universita degli studi La Sapienza
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Universita degli Studi La Sapienza
City
Roma
ZIP/Postal Code
00185
Country
Italy
Facility Name
Nevrologisk avdelning, 10 etasje
City
Lillehammer
ZIP/Postal Code
2609
Country
Norway
Facility Name
Sandvika Neurologpraksis
City
Sandvika
ZIP/Postal Code
1338
Country
Norway
Facility Name
Avd. for nevrologi og klinisk nevrofysiologi
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
Facility Name
University Hospital of Wales
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
University Hospital of North Staffordshire Royal Infirmary
City
Stoke On Trent
ZIP/Postal Code
ST4 7LN
Country
United Kingdom

12. IPD Sharing Statement

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Open Label, Zonegran (Zonisamide) In Partial Onset Seizures

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