Iis la Fe
Valencia, 46026, Spain
NCT Number: NCT01858870
Lacosamide is an antiepileptic drug approved for using like adjuvant treatment in adults epileptic crisis.
Previous studies has granted to the adjuvant therapy a significant efficacy. This is an observational study, multicenter and retrospective, in patients with epilepsy. The aim of study is the evaluation of the adjuvant treatment with Lacosamide administered over 12 months.
The investigators will collect information from 860 patients in 13 spanish centers.
The secondary aim is assess the tolerability of treatment during 3,6 and 12 month.
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Notify Me18 year and older
All sexes
Observational
Valencia, 46026, Spain
During the treatment we will performed a analysis in three different times (3, 6 and 12 month)for obtain a vision of tolerability and efficacy for Lacosamide in usual clinical practice. We intended describe the differences when we add Lacosamide to an antiepileptic drug, sodium channel blocker or no-sodium channel blocker in usual clinical practice.
Clinical data obtained through post-hoc analysis for registered pivotal studies made in highly refractory epileptic patients show that adjuvant treatment with Lacosamide has an extra efficacy compared with placebo. It is self-depended to the treatment with or without sodium channel blockers.
This study will allow us to obtain information about real existing most population where do not exist as high refractoriness as the pivotal studies.
The population of study is:
Patients with epilepsy, with plus that 18 years old patients, with initial partial crisis treated with Lacosamide according to usual clinical practice in Spain.
Lacosamide must has been used for epilepsy treatment at least during 12 month.
The data record is collection in 5 months.
Inclusion criteria
Exclusion criteria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
routine clinical practice
Other names: Vimpat 50mg; 100mg; 150mg; 200mg
Time frame: twelve months
The primary objective of the study is to assess the efficacy of through in patients with Partial Crisis, with a minimum duration of 12 months.
Time frame: twelve months
The secondary objective is to assess the tolerability of treatment with through in patients with Partial Crisis at 3, 6 and 12 months.
Instituto de Investigacion Sanitaria La Fe
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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