Observational Retrospective Study of Effectivity and Tolerability in Patients With Lacosamide Medication
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 860
- Locations
- 1
- Primary Endpoint
- The percentage of responders (patients with a crisis reduction of> 50%) at 12 months of treatment.
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The patient, male or female, over 18 years.
- •The patient has a diagnosis of prostate cancer of any kind, and has been treated with Lacosamide according to routine clinical practice.
- •The patient had at least one Partial Crisis during the year prior to initiation of treatment with Lacosamide.
- •The patient or their legal representative is reliable and able to adhere to the protocol (ie, is able to understand and complete the interview at the study visit), at the discretion of the investigator.
Exclusion Criteria
- •Patient is participating in another study of a medicinal product research (PMI) or a medical implant.
- •Patients with other types of epilepsy.
- •Patients with a history of chronic alcoholism or drug abuse in the last year.
- •Patients who are not in possession of his faculties at the time of obtaining the Informed Consent.
Arms & Interventions
Lacosamide
patients with Partial Crisis of epilepsy treated with Lacosamide for at least 12 months
Intervention: lacosamide (Drug)
Outcomes
Primary Outcomes
The percentage of responders (patients with a crisis reduction of> 50%) at 12 months of treatment.
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.
Secondary Outcomes
- Percentage of patients reporting Adverse Events spontaneously potentially caused by the drug.(twelve months)