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)

Completed

• Conditions: Partial Onset Seizures
• Interventions: Drug: Zonisamide tablets

• Registration Number: NCT01830868
• Lead Sponsor: Eisai Inc.

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

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2013-04-10
• Study First Submitted QC: 2013-04-11
• Study First Posted: 2013-04-12
• Primary Completion: 2013-06
• Study Completion: 2013-08
• Status Verified: 2018-02
• Last Update Submitted: 2023-06-16
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Zonisamide tablets	Zonisamide tablets	-

Primary Outcome Measures

Name	Time	Method
Retention Rate of Zonisamide (ZNS) after 6 months from Baseline	Up to 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in Seizure Frequency after 3 and 6 months from Baseline	Baseline, 3 months and 6 months	Change in overall seizure frequency calculated as absolute and percent changes after 3 and 6 months from baseline compared to the seizure frequency 3 months before introduction of ZNS.