EpilepsyNCT01858870
Observational Retrospective Study of Effectivity and Tolerability in Patients With Lacosamide Medication
An observational study of Epilepsy, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- lacosamide
- How many people
- 860 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2012to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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:
- Adults (+18).
- Patients with epilepsy partial crisis diagnostic that had been treated with Lacosamide according to usual clinical practice.
- The patient had at least one partial crisis during the year before to the initiation of treatment with Lacosamide.
- The patient or their legal agent is reliable and is be able to adhere to the protocol according to the investigation criteria.
Exclusion criteria:
- Patient is in an other study of medical protocol or medical implant.
- Patients with other kind of epilepsy.
- patients with chronic alcoholism or abuse drug recording in the last year.
- patients who don't be in possession of their faculties in the moment to sign Informed Consent.
- Conditions
- Epilepsy
- Being tested
- lacosamide
- Keywords
- Lacosamide, Partial Crisis
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lacosamideDrug
Also called Vimpat 50mg; 100mg; 150mg; 200mg
routine clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Lacosamide | patients with Partial Crisis of epilepsy treated with Lacosamide for at least 12 months Receives: Drug: lacosamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startApr 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 860 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigacion Sanitaria La Fe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vicente V Villanueva, doctor, Principal investigator, Iis la Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858870
- Sponsor's protocol ID
- LACO-EXP
- Status last verified
- Dec 2012
- First submitted
- 13 May 2013
- Last updated
- 21 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Retrospective Study of Effectivity and Tolerability in Patients With Lacosamide Medication
- ClinicalTrials.gov ID
- NCT01858870
- Acronym / sponsor ID
- LACO-EXP
- Conditions
- Epilepsy
- Keywords
- Lacosamide, Partial Crisis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 860 participants (actual)
- Lead sponsor
- Instituto de Investigacion Sanitaria La FeUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 21 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Lacosamide must has been used for epilepsy treatment at least during 12 month.
The data record is collection in 5 months.
Inclusion criteria:
- Adults (+18).
- Patients with epilepsy partial crisis diagnostic that had been treated with Lacosamide according to usual clinical practice.
- The patient had at least one partial crisis during the year before to the initiation of treatment with Lacosamide.
- The patient or their legal agent is reliable and is be able to adhere to the protocol according to the investigation criteria.
Exclusion criteria:
- Patient is in an other study of medical protocol or medical implant.
- Patients with other kind of epilepsy.
- patients with chronic alcoholism or abuse drug recording in the last year.
- patients who don't be in possession of their faculties in the moment to sign Informed Consent.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lacosamide | – | Drug: lacosamidepatients with Partial Crisis of epilepsy treated with Lacosamide for at least 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lacosamideAlso: Vimpat 50mg; 100mg; 150mg; 200mgroutine clinical practice | Drug | Lacosamide |
Primary outcome
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.
1 secondary outcome
Percentage of patients reporting Adverse Events spontaneously potentially caused by the drug.
Time frame: twelve months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vicente V Villanueva, doctor principal investigator
Iis la Fe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of responders (patients with a crisis reduction of> 50%) at 12 months of treatment. (time frame: twelve months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2013.