Open Label, Zonegran (Zonisamide) In Partial Onset Seizures

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00215592
• Other study ID #: E2090-E044-401
• Secondary ID: 2005-001982-33
• Status: Completed
• Phase: Phase 4
• First received: September 14, 2005
• Last updated: January 6, 2016
• Start date: October 2005

Study information

• Verified date: November 2015
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 ßHCG 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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Zonegran

Locations

Country	Name	City	State
Austria	Universitatsklinikum fur Neurologie	Innsbruck
Denmark	Danish Epilepsy Center	Dianalund
Denmark	The Epilepsy Clinic	Glostrup
France	Centre Hospitalier d'Annecy	Annecy cedex
France	CH Germon et Gauthier	Bethune
France	Hopital Pellegrin Tripode	Bordeaux cedex
France	Hopital Gabriel Montpied	Clermont-Ferrand Cedex 1
France	Hopital General	Dijon
France	Hopital Victor Jousselin	Dreux
France	Cabinet de neurologie	Gap
France	Hopital de la Timone Adultes	Marseille
France	Groupe hospitalier Pitie Salpetriere	Paris
France	Hopital de Font Pre	Toulon cedex
France	CHU Bretonneau	Tours Cedex
Germany	Universitatsklinikum Campus Virchow-Klinikum Wedding	Berlin
Germany	Epilepsieklinik Tabor	Bernau b. Berlin
Germany	Universitat Freiburg	Freiburg
Germany	Epilepsiezentrum Kork	Kehl-Kork
Germany	Arzneimittelforschung Leipzig GmbH	Leipzig
Germany	Klinik die Weissenau	Revensburg
Italy	Ospedale Riuniti di Bergamo	Bergamo
Italy	Azienda Ospedaliero- Universitaria Policlinico di Catania	Catania
Italy	Azienda Ospedaliera San Paolo	Milano
Italy	Istituto Nazionale Neurologico Carlo Besta di Milano	Milano
Italy	Universita di Parma	Parma
Italy	Azienda Ospedaliera Bianchi-Melancrino-Morelli	Reggio Calabria
Italy	Universita degli studi La Sapienza	Roma
Italy	Universita degli Studi La Sapienza	Roma
Norway	Nevrologisk avdelning, 10 etasje	Lillehammer
Norway	Sandvika Neurologpraksis	Sandvika
Norway	Avd. for nevrologi og klinisk nevrofysiologi	Trondheim
United Kingdom	University Hospital of Wales	Cardiff
United Kingdom	University Hospital of North Staffordshire Royal Infirmary	Stoke On Trent

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Limited

Countries where clinical trial is conducted

Austria,  Denmark,  France,  Germany,  Italy,  Norway,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seizure frequency, compared to baseline.