Clareo Health | Belgian Drug-utilization Study to Evaluate the Use of VIMPAT® as Adjunctive Treatment of Partial Onset Seizures in Subjects Aged 16 and Older
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
UCB Pharma
Age
16–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
