Open Label, Zonegran (Zonisamide) In Partial Onset Seizures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Limited )
ClinicalTrials.gov Identifier:
NCT00215592
First received: September 14, 2005
Last updated: June 26, 2014
Last verified: December 2012
  Purpose

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


Condition Intervention Phase
Epilepsy
Drug: Zonegran
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Study Of Zonegran (Zonisamide) In Patients With Partial Onset Seizures

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

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

Estimated Enrollment: 1000
Study Start Date: October 2005
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00215592

Locations
Austria
Universitatsklinikum fur Neurologie
Innsbruck, Austria, 6020
Denmark
Danish Epilepsy Center
Dianalund, Denmark, 4293
The Epilepsy Clinic
Glostrup, Denmark, 2600
France
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
Germany
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
Italy
Ospedale Riuniti di Bergamo
Bergamo, Italy, 24128
Azienda Ospedaliero- Universitaria Policlinico di Catania
Catania, Italy, 95125
Azienda Ospedaliera San Paolo
Milano, Italy, 20142
Istituto Nazionale Neurologico Carlo Besta di Milano
Milano, Italy, 20133
Universita di Parma
Parma, Italy, 43100
Azienda Ospedaliera Bianchi-Melancrino-Morelli
Reggio Calabria, Italy, 89100
Universita degli Studi La Sapienza
Roma, Italy, 00185
Universita degli studi La Sapienza
Roma, Italy, 00161
Norway
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
Investigators
Study Director: Dr. Tone Bjaaland Eisai Limited
  More Information

No publications provided

Responsible Party: Eisai Inc. ( Eisai Limited )
ClinicalTrials.gov Identifier: NCT00215592     History of Changes
Other Study ID Numbers: E2090-E044-401, 2005-001982-33
Study First Received: September 14, 2005
Last Updated: June 26, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Zonisamide
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014