CompletedNot Applicable

Vimpat® Added as Adjunctive Therapy to One Baseline Antiepileptic Drug

Germany576 participantsStarted 2010-03

Plain-language summary

The purpose of this study is to systematically and prospectively collect data from patients with partial-onset seizures in routine clinical practice setting receiving adjunctive Vimpat®. The observed population will be only patients with one baseline antiepileptic drug. Seizure control and tolerability data will be evaluated.

Who can participate

Age range

16 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 patient's treatment must be in accordance with the local marketing authorization (MA) for Vimpat® * The decision to prescribe Vimpat® has to be made by the physician before and independently of his/her decision to include the patient in the study * The Vimpat® treatment should have been started not longer than 2 weeks before study inclusion of the patient * The patient must have a diagnosis of Epilepsy with Partial-Onset Seizures * Based on the physician's clinical judgment, the patient's seizure activity is not controlled sufficiently on a current monotherapy and it is in the patient's best interest to be prescribed adjunctive Vimpat® Exclusion Criteria: In accordance with the Summary of Product Characteristics (SmPC)

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

Clinical Global Impression of Change (CGI-C) at Month 6

Timeframe: Month 6

Trial details

NCT IDNCT01098162

SponsorUCB Pharma GmbH

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2013-07

Results submitted2014-06-24

View on ClinicalTrials.gov More Epilepsies, Partial trials