Clinical trial NCT01236001: Belgian Drug-utilization Study to Evaluate the Use of VIMPAT® as Adjunctive Treatment of Partial Onset Seizures in Subjects Aged 16 and Older
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Seizures
Keywords: Lacosamide
Vimpat®
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2010-11-07
Enrollment: 192
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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


Eligibility criteria: 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

Primary outcomes:
measure: Mean Total Daily Dose of VIMPAT® (mg) at Baseline
timeFrame: Baseline
measure: Mean Total Daily Dose of VIMPAT® (mg) at 3 Months
timeFrame: 3 months
measure: Mean Total Daily Dose of VIMPAT® (mg) at 6 Months
timeFrame: 6 months
measure: Galenic Formulation Repartition in Subjects Treated by VIMPAT® at Baseline
timeFrame: Baseline
measure: Galenic Formulation Repartition in Subjects Treated by VIMPAT® at 3 Months
timeFrame: 3 months
measure: Galenic Formulation Repartition in Subjects Treated by VIMPAT® at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of Subjects Who Received Concomitant Antiepileptic Drug Treatment
timeFrame: From baseline to study termination (6 months)
measure: Treatment Persistence of VIMPAT® After 6 Months
timeFrame: >=6 months
measure: Percentage of Subjects by Category of Clinical Evolution of Seizure Control at Baseline
timeFrame: Baseline
measure: Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 3 Months
timeFrame: 3 months
measure: Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 6 Months
timeFrame: 6 months
Other outcomes:
Locations:
city: Aalst
country: Belgium
city: Antwerpen
country: Belgium
city: Assebroek
country: Belgium
city: Brugge
country: Belgium
city: Brussels
country: Belgium
city: Charleroi
country: Belgium
city: Duffel
country: Belgium
city: Gent
country: Belgium
city: Hasselt
country: Belgium
city: La Louviere
country: Belgium
city: Leuven
country: Belgium
city: Liege
country: Belgium
city: Marche-en-Famenne
country: Belgium
city: Mons
country: Belgium
city: Montegnée - Liege
country: Belgium
city: Ottignies-Louvain-la-Neuve
country: Belgium
city: Yvoir
country: Belgium
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: