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

UCB

Status: Completed

Conditions: Seizures

Treatments: Drug: Lacosamide

Study type: Observational

Funder types: Industry

Identifiers

NCT01236001

SP1021

Details and patient eligibility

About

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

Enrollment: 192 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

192 participants in 1 patient group

Vimpat® treatment

Description:

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

Treatment:

Drug: Lacosamide