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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 192
- 主要终点
- Mean Total Daily Dose of VIMPAT® (mg) at Baseline
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Vimpat® treatment
Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
干预措施: Lacosamide (Drug)
结局指标
主要结局
Mean Total Daily Dose of VIMPAT® (mg) at Baseline
时间窗: 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
时间窗: 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
时间窗: 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.
Mean Total Daily Dose of VIMPAT® (mg) at 3 Months
时间窗: 3 months
Galenic Formulation Repartition in Subjects Treated by VIMPAT® at 6 Months
时间窗: 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
时间窗: 6 months
次要结局
- Treatment Persistence of VIMPAT® After 6 Months(>=6 months)
- Percentage of Subjects Who Received Concomitant Antiepileptic Drug Treatment(From baseline to study termination (6 months))
- Percentage of Subjects by Category of Clinical Evolution of Seizure Control at Baseline(Baseline)
- Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 6 Months(6 months)
- Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 3 Months(3 months)