Open Label, Zonegran (Zonisamide) In Partial Onset Seizures
An Open Label Study Of Zonegran (Zonisamide) In Patients With Partial Onset Seizures
2 other identifiers
interventional
1,000
7 countries
33
Brief Summary
To determine the efficacy and safety of adjunctive open label Zonegran treatment in patients with refractory partial seizures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedStudy Start
First participant enrolled
October 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedJanuary 8, 2016
November 1, 2015
1.7 years
September 14, 2005
January 6, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Seizure frequency, compared to baseline.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Limitedlead
Study Sites (33)
Universitatsklinikum fur Neurologie
Innsbruck, 6020, Austria
Danish Epilepsy Center
Dianalund, 4293, Denmark
The Epilepsy Clinic
Glostrup Municipality, 2600, Denmark
Centre Hospitalier d'Annecy
Annecy, 74011, France
CH Germon et Gauthier
BĂ©thune, 62408, France
Hopital Pellegrin Tripode
Bordeaux, 33076, France
Hopital Gabriel Montpied
Clermont-Ferrand, 63003, France
Hopital General
Dijon, 21033, France
Hopital Victor Jousselin
Dreux, 28102, France
Cabinet de neurologie
Gap, 05000, France
Hopital de la Timone Adultes
Marseille, 13385, France
Groupe hospitalier Pitie Salpetriere
Paris, 75651, France
Hopital de Font Pre
Toulon, 83056, France
CHU Bretonneau
Tours, 37044, France
Universitatsklinikum Campus Virchow-Klinikum Wedding
Berlin, 13353, Germany
Epilepsieklinik Tabor
Bernau B. Berlin, 16321, Germany
Universitat Freiburg
Freiburg im Breisgau, 79106, Germany
Epilepsiezentrum Kork
Kehl-Kork, 77694, Germany
Arzneimittelforschung Leipzig GmbH
Leipzig, 04107, Germany
Klinik die Weissenau
Revensburg, 88214, Germany
Ospedale Riuniti di Bergamo
Bergamo, 24128, Italy
Azienda Ospedaliero- Universitaria Policlinico di Catania
Catania, 95125, Italy
Istituto Nazionale Neurologico Carlo Besta di Milano
Milan, 20133, Italy
Azienda Ospedaliera San Paolo
Milan, 20142, Italy
Universita di Parma
Parma, 43100, Italy
Azienda Ospedaliera Bianchi-Melancrino-Morelli
Reggio Calabria, 89100, Italy
Universita degli studi La Sapienza
Roma, 00161, Italy
Universita degli Studi La Sapienza
Roma, 00185, Italy
Nevrologisk avdelning, 10 etasje
Lillehammer, 2609, Norway
Sandvika Neurologpraksis
Sandvika, 1338, Norway
Avd. for nevrologi og klinisk nevrofysiologi
Trondheim, 7006, Norway
University Hospital of Wales
Cardiff, CF14 4XW, United Kingdom
University Hospital of North Staffordshire Royal Infirmary
Stoke-on-Trent, ST4 7LN, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dr. Tone Bjaaland
Eisai Limited
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2005
First Posted
September 22, 2005
Study Start
October 1, 2005
Primary Completion
July 1, 2007
Last Updated
January 8, 2016
Record last verified: 2015-11