Open Label, Zonegran (Zonisamide) In Partial Onset Seizures
This study has been completed.
Sponsor:
Eisai Limited
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Limited )
ClinicalTrials.gov Identifier:
NCT00215592
First received: September 14, 2005
Last updated: December 6, 2012
Last verified: December 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Genetics Home Reference related topics:
pyridoxal 5'-phosphate-dependent epilepsy
Drug Information available for:
Zonisamide
U.S. FDA Resources
Further study details as provided by Eisai Inc.:
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
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 |
| Study First Received: | September 14, 2005 |
| Last Updated: | December 6, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Zonisamide Antioxidants Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Protective Agents Physiological Effects of Drugs Anticonvulsants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013