A Post-marketing Observational Study Of The Use Of Zonisamide (ZNS) in the Adjunctive Treatment O… (NCT01830868) | Clinical Trial Compass
CompletedNot Applicable
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)
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Retention Rate of Zonisamide (ZNS) after 6 months from Baseline