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

NCT01858870 | Completed DMC

• 1 other identifier: LACO-EXP
• Study Type: observational
• Target: 860
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Keywords

Lacosamide; Partial Crisis

Outcome Measures

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.

  twelve months

Secondary Outcomes (1)

• Percentage of patients reporting Adverse Events spontaneously potentially caused by the drug.

  twelve months

Study Arms (1)

Lacosamide

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

Drug: lacosamide

Interventions

lacosamide DRUG

routine clinical practice

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

Lacosamide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigacion Sanitaria La Fe: lead

Study Sites (1)

Iis la Fe

Valencia, Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Lacosamide

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids

Study Officials

• Vicente V Villanueva, doctor

  Iis la Fe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2013
• First Posted: May 21, 2013
• Study Start: April 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 21, 2013

Record last verified: 2012-12

Locations

ES (1)