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)
An Open-label, Multi-centre, Multi-national Post-marketing Non-interventional Observational Study of the Use of Zonisamide (ZNS) in the Adjunctive Treatment of Adult Patients With Partial Onset Seizures Treated With One Antiepileptic Drug (AED) as Baseline Medication
1 other identifier
observational
104
5 countries
37
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2012
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 10, 2013
CompletedFirst Posted
Study publicly available on registry
April 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedJune 18, 2023
February 1, 2018
1.3 years
April 10, 2013
June 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Retention Rate of Zonisamide (ZNS) after 6 months from Baseline
The retention rate or the proportion of patients still receiving ZNS after 6 months will be assessed. At each of the two visits after 3 months and 6 months (final assessment or early discontinuation), the clinician will record whether the patient is still on ZNS treatment, or whether treatment has been discontinued.
Up to 6 months
Secondary Outcomes (1)
Change in Seizure Frequency after 3 and 6 months from Baseline
Baseline, 3 months and 6 months
Study Arms (1)
Zonisamide tablets
Interventions
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.
Eligibility Criteria
Adult Patients With Partial Onset Seizures
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.lead
Study Sites (37)
Unknown Facility
Ried, Austria
Unknown Facility
Hillerød, Denmark
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Asperg, Germany
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Baesweiler, Germany
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Berlin, Germany
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Bielefeld, Germany
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Dortmund, Germany
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Eisenach, Germany
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Erbach im Odenwald, Germany
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Erlangen, Germany
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Fürth, Germany
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Gladenbach, Germany
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Hamburg, Germany
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Haßfurt, Germany
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Jülich, Germany
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Kastellaun, Germany
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Lage, Germany
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Lappersdorf, Germany
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Lauf, Germany
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Lohr a. Main, Germany
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Malchin, Germany
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Mönchengladbach, Germany
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München, Germany
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Neuburg an der Donau, Germany
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Neusäß, Germany
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Osnabrück, Germany
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Remscheid, Germany
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Saarbrücken, Germany
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Schorndorf, Germany
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Schwäbisch Gmünd, Germany
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Senftenberg, Germany
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Stralsund, Germany
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Stuttgart, Germany
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Ulm, Germany
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Velen, Germany
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Drammen, Norway
Unknown Facility
Stockholm, Sweden
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hajo Hamer, Dr.
Universitatsklinikum Erlangen, Schwabachanlage 6, 91054 Erlangen, Germany
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2013
First Posted
April 12, 2013
Study Start
March 1, 2012
Primary Completion
June 1, 2013
Study Completion
August 1, 2013
Last Updated
June 18, 2023
Record last verified: 2018-02