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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

192 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-03-31

Brief Summary

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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

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Detailed Description

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Conditions

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Seizures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Vimpat® treatment

Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.

Lacosamide

Intervention Type DRUG

Interventions

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Lacosamide

Intervention Type DRUG

Other Intervention Names

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VIMPAT®

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No