NCT05867160进行中（未招募）不适用
A 12-month, Prospective, Observational Study in Adult Patients With Focal Onset Seizures Who Are Treated With Adjunctive ASM in Real World Setting
Aziende Chimiche Riunite Angelini Francesco S.p.A1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年5月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change in seizure frequency at 6 months of maintenance
研究概览
简要总结
The purpose of this study is to describe the effectiveness of the adjunctive ASM treatment on the clinical response, safety profile and quality of life of patients affected by focal onset seizures in a real-world setting.
详细描述
The aim of the study is to assess the effectiveness and safety of adjunctive therapy in a real-world setting of patients affected by focal-onset seizures who are eligible to start the treatment with ASM as adjunctive therapy according to the physician's judgment.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients of any ethnic origin ≥18 years old at baseline.
- •Patients with diagnosis of focal-onset seizures with or without secondary generalization.
- •Patients should have been eligible to start treatment with ASM as adjunctive therapy according to the physician's judgement prior to the inclusion.
- •Patients should have clinical history of treatment failure with at least 2 ASMs.
- •Patients using their seizure diary as part of their standard of care for at least 3 months prior to -the study entry (diary can be paper or electronic, filled in by patient and/or family members).
- •Written informed consent (including data privacy consent) signed by the patient, legal guardian, or legally authorized representative prior to entering the study in accordance with the ICH GCP guidelines
排除标准
- •Patients who meet any of the contraindications to the administration of adjunctive ASMs according to their approved SmPC.
- •Progressive neurological disease, including degenerative CNS diseases and progressive tumors.
- •Patients with unstable psychiatric diagnosis that may confound participants' ability to participate in the study or that may prevent completion of the protocol-specified assessments (e.g., in the judgement of the Investigator, pose an appreciable risk for suicide, including suicidal behavior and ideation within 6 months prior to enrollment, current psychotic disorder, acute mania).
- •Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the Investigator could affect the participant's safety or interfere with study assessments.
- •Patients with substance abuse or dependence (except for caffeine and nicotine).
- •Patients participating in any pharmacological or nonpharmacological interventional study within 30 days prior to baseline.
结局指标
主要结局
Change in seizure frequency at 6 months of maintenance
时间窗: At 6 months of maintenance compared to baseline
The effectiveness of adjunctive ASM is measured as change in seizure frequency at 6 months of maintenance compared to baseline
次要结局
- Quality of life (QOL)(At baseline, immediately after completion of titration, at 3 months, 6 months, and 12 months of maintenance phase.)
- Change in seizure frequency at 3, 9, 12 months of maintenance(At 3, 9, 12 months of maintenance compared to baseline)
- Depression assessment(At baseline, immediately after completion of titration, at 3 months, 6 months, and 12 months of maintenance phase.)
- Cognitive assessment(At baseline, immediately after completion of titration, at 3 months, 6 months, and 12 months of maintenance phase.)
- 50, 75, 90 Percent Responder rate(At 3, 6, 9, and 12 months of maintenance phase.)
- 100 Percent Responder rate(At 3, 6, 9, and 12 months of maintenance phase.)
- Retention rate(At 3, 6, 9, and 12 months of maintenance phase.)
- Anxiety assessment(At baseline, immediately after completion of titration, at 3 months, 6 months, and 12 months of maintenance phase.)
- Adverse events (AEs)(Through study completion, an average of 1 year)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Single Arm Study With a Nitinol Self-Expanding Paclitaxel-Eluting Stent to Treat BTK ArteriesPeripheral Arterial DiseaseNCT01630070Flanders Medical Research Program70
Unknown
不适用
Effect of SAMe Treatment on Recurrence After Radical Treatment of Primary Hepatic CarcinomaPrimary Liver CancerNCT03178929Beijing Insight Science & Technology Co. Ltd.207
已完成
2 期
Spondylitis Trial of Apremilast for Better Rheumatic TherapyAnkylosing SpondylitisNCT00944658Imperial College London38
Unknown
1 期
Effect of S-Adenosyl Methionine Treatment on Recurrence After Curative Resection of Hepatocellular CarcinomaHepatocellular CarcinomaNCT02586285Eastern Hepatobiliary Surgery Hospital300
已完成
3 期
A Trial of CM-AT in Children With Autism With All Levels of FCT (The Blum Study)AutismNCT02410902Curemark190