Efficacy and Safety of an add-on Treatment With Zonisamide in Adults With Focal Epileptic Seizures With or Without Secondary Generalization

Epilepsy Clinical Trial

Official title:

Randomized Trial to Assess Efficacy and Safety of an add-on Treatment With Zonisamide in Adults With Focal Epileptic Seizures With or Without Secondary Generalization

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00165828
• Other study ID #: ZNS-D-04-001
• Secondary ID: 2005-000260-57
• Status: Terminated
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: June 26, 2014
• Start date: May 2005
• Est. completion date: February 2008

Study information

• Verified date: November 2013
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Bundesinstitut fur Arzneimittel und Medizinprodukte, Klinische Prufung
• Study type: Interventional

Clinical Trial Summary

Patients with focal epileptic seizures with or without generalization who are at present treated with one or two antiepileptic drugs are eligible for this study, provided that they fulfill all inclusion criteria and none of the exclusion criteria. Following a baseline phase of 8 weeks duration, the patients are randomised and they receive an initial daily dose of 50 mg zonisamide during the first week. The daily dose is then increased to 200 mg zonisamide in group A or 400 mg zonisamide in group B, respectively. After eight weeks of treatment, the daily dose in group A can be increased to 300 mg in case of insufficient efficacy. Control assessments are performed at the beginning of the study and at the end of the prospective baseline phase, if applicable and after 4, 8, 12, and 16 weeks. At the end of the first, second, and third treatment week, and at the end of week six, the patient is additionally contacted by telephone. Efficacy and safety parameters are assessed at baseline, during all control visits, and at the end of the study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 157
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 74 Years

Eligibility

Inclusion criteria at screening:

• Adult aged between 18 years and 74 years

• Focal epileptic seizures with or without secondary generalization

• Present treatment with one or two antiepileptic drugs (constant dosage during 8 weeks baseline phase prior to initiation of treatment with zonisamide). Stimulation of the vagus nerve is permitted and will not be counted as antiepileptic drug.

• For women of childbearing potential (postmenopausal for more than 1 year): possible pregnancy during the study can be excluded (by hysterectomy, sterilization or simultaneous application of two recognized methods of contraception (no oral contraceptives only)

• For male patients with partners of childbearing potential: a safe method of contraception is practiced during their study participation

• Written consent to participate in the study

Inclusion criteria for randomisation:

• At least 6 focal or clonicotonic seizures documented completely in a seizure diary or the patient chart during the 8 prospective or retrospective weeks baseline phase.

Exclusion criteria at screening:

• Epileptic state during the past year

• Non-epileptic fits

• Generalized epilepsy

• More than 4 weeks of seizure freedom during baseline phase

• Concomitant progressive CNS disease including progressive myoclonus epilepsy

• Concomitant treatment with vigabatrine and / or topiramate

• Hepatic and/or renal insufficiency (creatine > 2mg% or GPT > 2 times ULN)

• Body weight = 40 kg

• (History of) kidney stones; erythrocyturia, family history (in parents, children, brothers and sisters or grandparents) of kidney stones

• (History of) drug and/or alcohol dependence

• Active psychosis

• Suicide attempt during the past 3 years

• Pre-treatment with zonisamide

• Known hypersensitivity to sulfonamides

• concomitant treatment with neuroleptic drugs

• pregnant or breast feeding woman

• participation in another therapy study within 3 months prior to or during this study

• blood donation planned during or within 4 weeks after the participation in this study

• elective surgery planned during the participation in this study

• patient is not willing or not capable to meet the study demands

• patient does not agree to the forwarding of his/her pseudonymous data

• patient without legal competence

Exclusion criteria for randomisation:

• More than 4 consecutive weeks of freedom from seizure during baseline phase

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Zonegran
Intravenous injection; initial daily dose of 50 mg zonisamide (2x25 mg) in both treatment groups; following a prospective or retrospective baseline phase of 8 weeks the study drug will be administered twice daily during 16 consecutive weeks.

Locations

Country	Name	City	State
Germany	Epilepsiezentrum Bethel/KSE	Beilefeld
Germany	Charite Campus Virchow-Klinikum, Neurologische Klinik und Poliklinik	Berlin
Germany	Institut fur Diagnostik der Epilepsien Gmbh	Berlin
Germany	Epilepsieklinik Tabor	Bernau	Brandenburg
Germany	Dr. Gunther Schumann	Bochum
Germany	Knappschaftskrankenhaus Bochum-Langendreer, Neurologische Klinik	Bochum
Germany	St. Josephs Hospital, Neurologische Klinik	Bochum
Germany	Dr. Hans Martin Kolbinger	Bonn
Germany	Universtitatsklinikum Bonn	Bonn	Nordrhein-Westphalen
Germany	Neuro-Consil Gmbh	Dusseldorf
Germany	Neurologische Klinik der Universitat Erlangen	Erlangen
Germany	Universitatsklinik Essen, Klinik und Poliklinik fur Neurologie	Essen
Germany	Universitatsklinikum Freiburg, Neurozentrum	Freiburg
Germany	Universitatsklinikum Gottingen, Abt. fur klinische Neurophysiologie	Gottingen
Germany	Dr. Heinrich C. Braeuer	Hamburg
Germany	Ev. Krankenhaus Alsterdorf, Epilepsiezentrum Alsterdorf	Hamburg
Germany	Gemeinschaftpraxis fur Neurologie und Psychiatrie	Hamburg
Germany	Epilepsiezentrum Kork	Kehl
Germany	Epilepsiezentrum Kleinwachau, Epilepsieambulanz	Liegau-Augustusbad
Germany	Universitatsklinikum Mannheim, Neurologische Klinik, Ambulanz fur Anfallserkrankte	Mannheim
Germany	Universitatsklinikum, Interdisziplinares Epilepsiezentrum	Marburg
Germany	Klinikum Grosshadern, Neurologische Klinik und Poliklinik, Epilepsie-Ambulanz	Munchen
Germany	Universtitatsklinikum Munster, Klinik und Poliklinik fur Neurologie	Munster	Nordrhein-Westphalen
Germany	Klinikum Offenbach, Neurologie	Offenbach
Germany	Klinik Ernst von Bergmann	Potsdam
Germany	Universitat Regensburg, Klinik un Poliklinik fur Neurologie	Regensburg
Germany	Klinik "Die Weissenau", Anfallsambulanz	Revensburg
Germany	Universitat Rostock, Klinik fur Neurologie und Poliklinik	Rostock
Germany	Universitatsklinik Ulm Poliklinik fur Neurologie, Epilepsieambulanz	Ulm
Germany	Dr. Horst-Schmidt Klinik, Neurologie	Wiesbaden

Sponsors (1)

Lead Sponsor	Collaborator
Eisai GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number of epileptic seizures between week 13 and 16 after start of treatment compared to the correspondently normalized base-line phase.		28 days	Yes