A Post-marketing Observational Study Of The Use Of Zonisamide (ZNS) in the Adjunctive Treatment Of Adult Patients With Partial Onset Seizures (Study E2090-E044-410) (ZOOM)

NCT ID: NCT01830868

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 104 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-08-31

Brief Summary

This is a Non-interventional Prospective Study. Centres will enroll adult patients with partial onset seizures for whom the clinician has decided to initiate ZNS as an adjunctive therapy prior to the decision to take part in this study. Patients to be enrolled into the study are not sufficiently controlled with one dug licensed for the use of monotherapy in partial onset seizures. Patients will be seen at baseline and then during normal clinical visits at intervals which are appropriate to the typical practice of the treating clinician. Patients will be assessed at baseline and then at least 3 and 6 months after the baseline.

Detailed Description

Open-label, Multi-centre, Multi-national Post-marketing, Non-interventional Observational Study

Conditions

Partial Onset Seizures

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Zonisamide tablets

Zonisamide tablets

Intervention Type: DRUG

The recommended initial daily dose is 50 mg in two divided doses. After one week the dose may be increased to 100 mg daily and thereafter the dose may be increased at weekly intervals, in increments of up to 100 mg. Doses of 300 mg to 500 mg per day have been shown to be effective, though some patients, especially those not taking CYP3A4 (cytochrome P450)-inducing agents, may respond to lower doses.

Interventions

Zonisamide tablets

The recommended initial daily dose is 50 mg in two divided doses. After one week the dose may be increased to 100 mg daily and thereafter the dose may be increased at weekly intervals, in increments of up to 100 mg. Doses of 300 mg to 500 mg per day have been shown to be effective, though some patients, especially those not taking CYP3A4 (cytochrome P450)-inducing agents, may respond to lower doses.

Intervention Type: DRUG

Other Intervention Names

ZNS

Eligibility Criteria

Inclusion Criteria

• The decision to prescribe ZNS was made by the physician before and independently of his/her decision to include the patient in the study
• Patients treated with one drug licensed for the use as monotherapy in partial onset seizures
• Based on the physician's clinical judgment, the patient seizure activity is not controlled sufficiently with the current monotherapy and it is in the patient's best interest to be prescribed adjunctive ZNS
• Patient was prescribed ZNS no longer than 2 weeks before baseline
• Treatment with ZNS has to be commenced in line with the drug's license and ZNS SmPC (Summary of Product Characteristics)
• Aged 18 years or older
• Capable of understanding the purpose of the study, fully informed and having given written informed consent.

Exclusion Criteria

• Patients that have started ZNS outside the approved SmPC at enrolment
• Simultaneous participation in an interventional clinical trial and/or taking an investigational drug
• Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the patient.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hajo Hamer, Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitatsklinikum Erlangen, Schwabachanlage 6, 91054 Erlangen, Germany

Locations

Ried, , Austria

Hillerød, , Denmark

Asperg, , Germany

Baesweiler, , Germany

Berlin, , Germany

Bielefeld, , Germany

Dortmund, , Germany

Eisenach, , Germany

Erbach im Odenwald, , Germany

Erlangen, , Germany

Fürth, , Germany

Gladenbach, , Germany

Hamburg, , Germany

Haßfurt, , Germany

Jülich, , Germany

Kastellaun, , Germany

Lage, , Germany

Lappersdorf, , Germany

Lauf, , Germany

Lohr a. Main, , Germany

Malchin, , Germany

Mönchengladbach, , Germany

München, , Germany

Neuburg an der Donau, , Germany

Neusaß, , Germany

Osnabrück, , Germany

Remscheid, , Germany

Saarbrücken, , Germany

Schorndorf, , Germany

Schwäbisch Gmünd, , Germany

Senftenberg, , Germany

Stralsund, , Germany

Stuttgart, , Germany

Ulm, , Germany

Velen, , Germany

Drammen, , Norway

Stockholm, , Sweden

Countries

Austria; Denmark; Germany; Norway; Sweden

Other Identifiers

E2090-E044-410

Identifier Type: -

Identifier Source: org_study_id