Observational Retrospective Study of Effectivity and Tolerability in Patients With Lacosamide Medication

Epilepsy Clinical Trial

Official title:

Observational Retrospective Study of Effectivity and Tolerability in Patients With Lacosamide Medication

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01858870
• Other study ID #: LACO-EXP
• Status: Completed
• Phase: N/A
• First received: May 13, 2013
• Last updated: May 20, 2013
• Start date: April 2012
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: Instituto de Investigacion Sanitaria La Fe
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of MedicinesSpain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial 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.

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.

Lacosamide must has been used for epilepsy treatment at least during 12 month.

The data record is collection in 5 months.

Inclusion criteria:

1. Adults (+18).

2. Patients with epilepsy partial crisis diagnostic that had been treated with Lacosamide according to usual clinical practice.

3. The patient had at least one partial crisis during the year before to the initiation of treatment with Lacosamide.

4. The patient or their legal agent is reliable and is be able to adhere to the protocol according to the investigation criteria.

Exclusion criteria:

1. Patient is in an other study of medical protocol or medical implant.

2. Patients with other kind of epilepsy.

3. patients with chronic alcoholism or abuse drug recording in the last year.

4. patients who don't be in possession of their faculties in the moment to sign Informed Consent.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 860
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. The patient, male or female, over 18 years.

2. The patient has a diagnosis of prostate cancer of any kind, and has been treated with Lacosamide according to routine clinical practice.

3. The patient had at least one Partial Crisis during the year prior to initiation of treatment with Lacosamide.

4. 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:

1. Patient is participating in another study of a medicinal product research (PMI) or a medical implant.

2. Patients with other types of epilepsy.

3. Patients with a history of chronic alcoholism or drug abuse in the last year.

4. Patients who are not in possession of his faculties at the time of obtaining the Informed Consent.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• lacosamide
routine clinical practice

Locations

Country	Name	City	State
Spain	Iis la Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigacion Sanitaria La Fe

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of responders (patients with a crisis reduction of> 50%) at 12 months of treatment.	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.	twelve months	Yes
Secondary	Percentage of patients reporting Adverse Events spontaneously potentially caused by the drug.	The secondary objective is to assess the tolerability of treatment with through in patients with Partial Crisis at 3, 6 and 12 months.	twelve months	Yes