Belgian Drug-utilization Study to Evaluate the Use of VIMPAT® as Adjunctive Treatment of Partial Onset Seizures in Subjects Aged 16 and Older
- Registration Number
- NCT01236001
- Lead Sponsor
- UCB Pharma
- Brief 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 treatment duration
* Discontinuation rate
* Description of any changes in other epilepsy therapies
* Safety and tolerability
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 192
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Vimpat® treatment Lacosamide Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
- Primary Outcome Measures
Name Time Method Mean Total Daily Dose of VIMPAT® (mg) at 3 Months 3 months Mean Total Daily Dose of VIMPAT® (mg) at Baseline Baseline Mean total daily dose at baseline will be only provided for subjects who were already treated by VIMPAT® at Baseline.
Galenic Formulation Repartition in Subjects Treated by VIMPAT® at Baseline 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 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 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.
Mean Total Daily Dose of VIMPAT® (mg) at 6 Months 6 months
- Secondary Outcome Measures
Name Time Method Treatment Persistence of VIMPAT® After 6 Months >=6 months Treatment persistence is defined as the percentage of subjects being treated under VIMPAT® after a given duration (\>=6 months).
Percentage of Subjects Who Received Concomitant Antiepileptic Drug Treatment From baseline to study termination (6 months) Concomitant antiepileptic drug (AED) treatments are defined as treatments which started after or at the date of the first administration of VIMPAT®.
Percentage of Subjects by Category of Clinical Evolution of Seizure Control at Baseline 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.Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 6 Months 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
Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 3 Months 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.