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CompletedNCT01858870Updated May 21, 2013

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

An observational study in Epilepsy, sponsored by Instituto de Investigacion Sanitaria La Fe. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-21.

Sponsored by Instituto de Investigacion Sanitaria La Fe · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
860
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

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.
02

Conditions studied

  • Epilepsy

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Keywords

  • Lacosamide
  • Partial Crisis
03

In context

Epilepsy

1,804 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 860 is above the median of 102 across 521 observational studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Instituto de Investigacion Sanitaria La Fe is the lead sponsor of 57 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The study is designed to collect data from patients with epilepsy, aged 18 years with partial onset seizures (Partial Crisis) treated with Lacosamide as routine clinical practice in Spain. Lacosamide must have been used for the treatment of Partial Crisis for at least 12 months. We intend to collect data from approximately 860 patients in 13 Spanish centers.

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

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.
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
860 participants (actual)
Patient registry
No

Groups and cohorts

  • Lacosamide

    patients with Partial Crisis of epilepsy treated with Lacosamide for at least 12 months

    Drug: lacosamide

Interventions

  • Druglacosamide

    routine clinical practice

    Also known as: Vimpat 50mg; 100mg; 150mg; 200mg

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: twelve months

Secondary outcomes

  1. 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.

    Time frame: twelve months

07

Study locations

1 site
  • Iis la Fe
    Valencia, 46026, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01858870
Lead sponsor
Instituto de Investigacion Sanitaria La Fe
Responsible party
Sponsor
First posted
May 21, 2013
Start date
Apr 2012
Primary completion
Dec 2012
Completion
Dec 2012
Last update
May 21, 2013

Study contacts

Vicente V Villanueva, doctor
principal investigator · Iis la Fe

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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