SeizuresNCT01236001

Belgian Drug-utilization Study to Evaluate the Use of VIMPAT® as Adjunctive Treatment of Partial Onset Seizures in Subjects Aged 16 and Older

An observational study of Seizures, run by UCB Pharma at 17 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Observational study at the request of the Belgian Institut National d'Assurance Maladie-Invalidité / Rijksinstituut voor Ziekte-en Invaliditeits Verzekering INAMI/RIZIV: type of patient treated with VIMPAT® VIMPAT® dose Effect of VIMPAT® on evolution of seizure control Persistence rate at 6 months in terms of… Read more about this study

Who is it for?: Ages 16 years and older
Conditions the study is for: Seizures
What is being tested?: Lacosamide
How many people: 192 participants
Where: 17 sitesBelgium
Study dates: Sep 2010to Mar 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Routine clinical practice of neurologist / neuropsychiatrist / neurosurgeon / neuropediatrician Sampling based upon request by the Belgian reimbursement authorities: request to report on 100 patients

Who may be able to join

An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form
Subject/legal representative is considered reliable and capable of adhering to the medication intake according to the judgement of the investigator
Based on the investigators clinical judgement, the subjects' seizure activity is uncontrolled on current therapy and it is in the subjects' best interest to be prescribed an antiepileptic drug (AED) as adjunctive therapy. The choice to prescribe VIMPAT® as adjunctive therapy is made by the treating investigator
The subject is aged 16 or older
The subject has a diagnosis of epilepsy with partial-onset seizures according to the label
The subject has a medication history with at least 3 AED therapies (lifetime and/or concomitant) with treatment failure: due to insufficient efficacy, due to significant adverse events
Sufficient data on the clinical situation before start of VIMPAT® and information on VIMPAT® dosing are present in the subject's medical record for patients on treatment with VIMPAT® at the time of enrollment into the study

Who cannot join

The subject has previously participated in this study or has participated in a clinical trial within the last 2 months
The subject has a history of chronic alcohol or drug abuse within the last 6 months
The subject has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study
The subject has a known hypersensitivity and/or allergy to soya, peanuts, or any component of VIMPAT®
The subject is pregnant or lactating
The subject has a known AV-block degree 2 or 3
The subject is expected to be insufficiently compliant with contraception.
The subject has a history of suicide attempt, has received professional counseling for suicidal ideation, or is currently experiencing active suicidal ideation

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

Belgium17 sites

Study site
Aalst
Study site
Antwerp
Study site
Assebroek
Study site
Bruges
Study site
Brussels
Study site
Charleroi
Study site
Duffel
Study site
Ghent
Study site
Hasselt
Study site
La Louvière
Study site
Leuven
Study site
Liège
Study site
Marche-en-Famenne
Study site
Mons
Study site
Montegnée - Liege
Study site
Ottignies-Louvain-la-Neuve
Study site
Yvoir

Other trials in Belgium

About this study

Official title: Multi-center, Observational, Drug-utilization Study in Belgium to Evaluate the Use of VIMPAT® in Clinical Practice as Adjunctive Treatment of Partial Onset Epilepsy in Subjects Aged 16 and Older.

Observational study at the request of the Belgian Institut National d'Assurance Maladie-Invalidité / Rijksinstituut voor Ziekte-en Invaliditeits Verzekering INAMI/RIZIV:

type of patient treated with VIMPAT®
VIMPAT® dose
Effect of VIMPAT® on evolution of seizure control
Persistence rate at 6 months in terms of treatment duration
Discontinuation rate
Description of any changes in other epilepsy therapies
Safety and tolerability

Conditions: Seizures
Being tested: Lacosamide
Keywords: Lacosamide, Vimpat®
Medical subject headings: Seizures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LacosamideDrug
Also called VIMPAT®

Study groups in NCT01236001
Study group	Role	What they receive
Vimpat® treatment		Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment. Receives: Drug: Lacosamide

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Total Daily Dose of VIMPAT® (mg) at Baseline
Mean total daily dose at baseline will be only provided for subjects who were already treated by VIMPAT® at Baseline.
Measured: Baseline
Mean Total Daily Dose of VIMPAT® (mg) at 3 Months
Measured: 3 months
Mean Total Daily Dose of VIMPAT® (mg) at 6 Months
Measured: 6 months
Galenic Formulation Repartition in Subjects Treated by VIMPAT® at Baseline
This outcome will be only provided for subjects who were already treated by VIMPAT® at Baseline.
VIMPAT is available as tablet and oral solution formulation in Belgium. The use of each galenic formulation will be presented with number of subjects by formulation.
Measured: Baseline
Galenic Formulation Repartition in Subjects Treated by VIMPAT® at 3 Months
VIMPAT is available as tablet and oral solution formulation in Belgium. The use of each galenic formulation will be presented with number of subjects by formulation.
Measured: 3 months
Galenic Formulation Repartition in Subjects Treated by VIMPAT® at 6 Months
VIMPAT is available as tablet and oral solution formulation in Belgium. The use of each galenic formulation will be presented with number of subjects by formulation.
Measured: 6 months

Secondary outcomes (5)

Percentage of Subjects Who Received Concomitant Antiepileptic Drug Treatment
Concomitant antiepileptic drug (AED) treatments are defined as treatments which started after or at the date of the first administration of VIMPAT®.
Measured: From baseline to study termination (6 months)
Treatment Persistence of VIMPAT® After 6 Months
Treatment persistence is defined as the percentage of subjects being treated under VIMPAT® after a given duration (>=6 months).
Measured: >=6 months
Percentage of Subjects by Category of Clinical Evolution of Seizure Control at Baseline
This outcome will be only provided for subjects who were already treated by VIMPAT® at Baseline.
Clinical evolution of seizures following administration of VIMPAT compared to baseline before start of VIMPAT. The evolution of seizure control is subjectively assessed by the investigator on a four categorical scale, with options being 1=worsened, 2=stable, 3=improved, 4=much improved. If seizure control is worse, the investigator will try to document the reason.
Measured: Baseline
Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 3 Months
Clinical evolution of seizures following administration of VIMPAT compared to baseline before start of VIMPAT. The evolution of seizure control is subjectively assessed by the investigator on a four categorical scale, with options being 1=worsened, 2=stable, 3=improved, 4=much improved. If seizure control is worse, the investigator will try to document the reason.
Measured: 3 months
Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 6 Months
Clinical evolution of seizures following administration of VIMPAT compared to baseline before start of VIMPAT. The evolution of seizure control is subjectively assessed by the investigator on a four categorical scale, with options being 1=worsened, 2=stable, 3=improved, 4=much improved. If seizure control is worse, the investigator will try to document the reason
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2010Mar 2012

First posted8 Nov 2010 (estimated)
Study startSep 2010
Primary completionMar 2012
Study completionMar 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SeizuresStudies 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: Cohort
Time perspective: Prospective
Enrolment: 192 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01236001
Sponsor's protocol ID: SP1021
Status last verified: Aug 2013
First submitted: 5 Nov 2010
Last updated: 8 Aug 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Electrophysiological Dose-Response to Anterior Thalamic Deep Brain Stimulation in Drug-Resistant Focal Epilepsy
Drug Resistant Epilepsy, Focal Epilepsy
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
Recruiting
FITting Non-invasive Tests in Lynch Syndrome Surveillance
Colorectal Cancer
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A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures
Primary Generalized Tonic-Clonic Seizures
Recruiting
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All Seizures trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi-center, Observational, Drug-utilization Study in Belgium to Evaluate the Use of VIMPAT® in Clinical Practice as Adjunctive Treatment of Partial Onset Epilepsy in Subjects Aged 16 and Older.
ClinicalTrials.gov ID: NCT01236001
Acronym / sponsor ID: SP1021
Conditions: Seizures
Keywords: Lacosamide, Vimpat®
Study type: Observational
Recruitment status: Completed
Enrolment: 192 participants (actual)
Lead sponsor: UCB PharmaIndustry (pharma, biotech, devices)
Study start: Sep 2010
Primary completion: Mar 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 8 Nov 2010 (estimated)
Results: Posted 8 Aug 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Observational study at the request of the Belgian Institut National d'Assurance Maladie-Invalidité / Rijksinstituut voor Ziekte-en Invaliditeits Verzekering INAMI/RIZIV:

type of patient treated with VIMPAT®
VIMPAT® dose
Effect of VIMPAT® on evolution of seizure control
Persistence rate at 6 months in terms of treatment duration
Discontinuation rate
Description of any changes in other epilepsy therapies
Safety and tolerability

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Vimpat® treatment	–	Drug: LacosamidePatients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Routine clinical practice of neurologist / neuropsychiatrist / neurosurgeon / neuropediatrician Sampling based upon request by the Belgian reimbursement authorities: request to report on 100 patients

Key inclusion criteria (7 listed)

An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form
Subject/legal representative is considered reliable and capable of adhering to the medication intake according to the judgement of the investigator
Based on the investigators clinical judgement, the subjects' seizure activity is uncontrolled on current therapy and it is in the subjects' best interest to be prescribed an antiepileptic drug (AED) as adjunctive therapy. The choice to prescribe VIMPAT® as adjunctive therapy is made by the treating investigator
The subject is aged 16 or older
The subject has a diagnosis of epilepsy with partial-onset seizures according to the label

Key exclusion criteria (8 listed)

The subject has previously participated in this study or has participated in a clinical trial within the last 2 months
The subject has a history of chronic alcohol or drug abuse within the last 6 months
The subject has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study
The subject has a known hypersensitivity and/or allergy to soya, peanuts, or any component of VIMPAT®
The subject is pregnant or lactating

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®	Drug	Vimpat® treatment

Primary outcome

Mean Total Daily Dose of VIMPAT® (mg) at Baseline
Time frame: Baseline
Mean total daily dose at baseline will be only provided for subjects who were already treated by VIMPAT® at Baseline.
Mean Total Daily Dose of VIMPAT® (mg) at 3 Months
Time frame: 3 months
Mean Total Daily Dose of VIMPAT® (mg) at 6 Months
Time frame: 6 months
Galenic Formulation Repartition in Subjects Treated by VIMPAT® at Baseline
Time frame: Baseline
This outcome will be only provided for subjects who were already treated by VIMPAT® at Baseline. VIMPAT is available as tablet and oral solution formulation in Belgium. The use of each galenic formulation will be presented with number of subjects by formulation.
Galenic Formulation Repartition in Subjects Treated by VIMPAT® at 3 Months
Time frame: 3 months
VIMPAT is available as tablet and oral solution formulation in Belgium. The use of each galenic formulation will be presented with number of subjects by formulation.
Galenic Formulation Repartition in Subjects Treated by VIMPAT® at 6 Months
Time frame: 6 months
VIMPAT is available as tablet and oral solution formulation in Belgium. The use of each galenic formulation will be presented with number of subjects by formulation.

5 secondary outcomes

Percentage of Subjects Who Received Concomitant Antiepileptic Drug Treatment
Time frame: From baseline to study termination (6 months)
Treatment Persistence of VIMPAT® After 6 Months
Time frame: >=6 months
Percentage of Subjects by Category of Clinical Evolution of Seizure Control at Baseline
Time frame: Baseline
Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 3 Months
Time frame: 3 months
Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 6 Months
Time frame: 6 months

Results and safety

Results posted to the registry on 8 Aug 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients Treated With VIMPAT® Prior to Enrollment	105	87
Patients Who Started VIMPAT® Treatment on/After Enrollment	87	65

Primary outcome: Mean Total Daily Dose of VIMPAT® (mg) at Baseline

Time frame: Baseline. Mean (Standard Deviation). Unit: mg/day of Vimpat

Measure	Patients Treated With VIMPAT® Prior to Enrollment n = 105
Value	272.1 (114.4)

Population analysed: Of the 192 subjects in the Safety Set (SS), 105 subjects were treated with Vimpat at Baseline are included in this analysis.

Primary outcome: Mean Total Daily Dose of VIMPAT® (mg) at 3 Months

Time frame: 3 months. Mean (Standard Deviation). Unit: mg/day of Vimpat

Measure	Patients Treated With VIMPAT® Prior to Enrollment n = 74	Patients Who Started VIMPAT® Treatment on/After Enrollment n = 63	Total Population n = 137
Value	316.2 (106.7)	211.1 (77.4)	267.9 (107.7)

Population analysed: Of the 192 subjects in the Safety Set (SS), 137 subjects had Vimpat daily dosing information available at the 3-month visit and are included in this analysis.

Primary outcome: Mean Total Daily Dose of VIMPAT® (mg) at 6 Months

Time frame: 6 months. Mean (Standard Deviation). Unit: mg/day of Vimpat

Measure	Patients Treated With VIMPAT® Prior to Enrollment n = 87	Patients Who Started VIMPAT® Treatment on/After Enrollment n = 67	Total Population n = 154
Value	329.9 (119.5)	262.7 (103.9)	300.6 (117.5)

Population analysed: Of the 192 subjects in the Safety Set (SS), 154 subjects had Vimpat dosing data available at the 6-month visit and are included in this analysis.

Primary outcome: Galenic Formulation Repartition in Subjects Treated by VIMPAT® at Baseline

Time frame: Baseline. Number. Unit: participants

Measure	Patients Treated With VIMPAT® Prior to Enrollment n = 105
Tablet	104
Oral Solution	1

Population analysed: Of the 192 subjects in the Safety Set (SS), 105 subjects were treated with Vimpat at Baseline are included in this analysis.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vimpat® Treatment	8 of 192 (4.2%)	74 of 192 (38.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Seizures

Not yet recruiting
Electrophysiological Dose-Response to Anterior Thalamic Deep Brain Stimulation in Drug-Resistant Focal Epilepsy
Drug Resistant Epilepsy, Focal Epilepsy
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
Recruiting
FITting Non-invasive Tests in Lynch Syndrome Surveillance
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RecruitingPhase 3
A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures
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Recruiting
Mapping of Human Cognition
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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.

UCB Clinical Trial Call Center study director

+1 877 822 9493 (UCB)

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Seizures, run by UCB Pharma at 17 sites in Belgium.

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 7 inclusion and 8 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 8 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Belgium. 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?

Yes. Results are posted in the registry (first posted 8 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Total Daily Dose of VIMPAT® (mg) at Baseline (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01236001.

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 8 Aug 2013.