Status:
COMPLETED
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)
Lead Sponsor:
Eisai Inc.
Conditions:
Partial Onset Seizures
Eligibility:
All Genders
18+ years
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 ...
Detailed Description
Open-label, Multi-centre, Multi-national Post-marketing, Non-interventional Observational Study
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT01830868
Start Date
March 1 2012
End Date
August 1 2013
Last Update
June 18 2023
Active Locations (37)
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1
Ried, Austria
2
Hillerød, Denmark
3
Asperg, Germany
4
Baesweiler, Germany