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

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

Study Overview

• Status: Completed
• Conditions: Seizures
• Intervention / Treatment: Drug: Lacosamide

• Study Type: Observational
• Enrollment (Actual): 192

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium
  • Antwerpen, Belgium
  • Assebroek, Belgium
  • Brugge, Belgium
  • Brussels, Belgium
  • Charleroi, Belgium
  • Duffel, Belgium
  • Gent, Belgium
  • Hasselt, Belgium
  • La Louviere, Belgium
  • Leuven, Belgium
  • Liege, Belgium
  • Marche-en-Famenne, Belgium
  • Mons, Belgium
  • Montegnée - Liege, Belgium
  • Ottignies-Louvain-la-Neuve, Belgium
  • Yvoir, Belgium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vimpat® treatment; Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.	Drug: Lacosamide; Other Names: VIMPAT®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline
Mean Total Daily Dose of VIMPAT® (mg) at 3 Months		3 months
Mean Total Daily Dose of VIMPAT® (mg) at 6 Months		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.	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.	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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®.	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).	>=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.	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.	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	6 months

Collaborators and Investigators

• Sponsor: UCB Pharma

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: November 5, 2010
• First Submitted That Met QC Criteria: November 5, 2010
• First Posted (Estimate): November 7, 2010

Study Record Updates

• Last Update Posted (Estimate): August 8, 2013
• Last Update Submitted That Met QC Criteria: August 6, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Lacosamide; Vimpat®
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Seizures; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lacosamide
• Other Study ID Numbers: SP1021