Belgian Drug-utilization Study to Evaluate the Use of VIMPAT® as Adjunctive Treatment of Partial Onset Seizures in Subjects Aged 16 and Older
NCT ID: NCT01236001
Last Updated: 2013-08-08
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
192 participants
OBSERVATIONAL
2010-09-30
2012-03-31
Brief Summary
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* 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
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Conditions
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Keywords
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Study Design
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COHORT
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
Interventions
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Lacosamide
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
16 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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Aalst, , Belgium
Antwerp, , Belgium
Assebroek, , Belgium
Bruges, , Belgium
Brussels, , Belgium
Charleroi, , Belgium
Duffel, , Belgium
Ghent, , Belgium
Hasselt, , Belgium
La Louvière, , Belgium
Leuven, , Belgium
Liège, , Belgium
Marche-en-Famenne, , Belgium
Mons, , Belgium
Montegnée - Liege, , Belgium
Ottignies-Louvain-la-Neuve, , Belgium
Yvoir, , Belgium
Countries
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Other Identifiers
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SP1021
Identifier Type: -
Identifier Source: org_study_id