2024-514499-42-00招募中3 期
A Double-Blind, Randomized, Placebo and Active Controlled Study to Evaluate the Efficacy and Safety of Once Daily, Extended Release Levetiracetam as Add-on Therapy in Patients with Refractory Partial Onset Epilepsy.
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 122
- 试验地点
- 41
- 主要终点
- Percent change from baseline* in FOS frequency per week over the 12 week double-blind period.
研究概览
简要总结
The primary objective is to assess the reduction in weekly Focal Onset Seizures (FOS) frequency of levetiracetam extended release (XR) compared to levetiracetam immediate release (IR) in subjects with drug-resistant FOS.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Safety
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 65+ years（65+ Years, 18-64 Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Male and female, between 12 and 80 years of age, both inclusive for Spain, Poland and Bulgaria while the other countries will include only adult subjects.
- •Willingness and capability to provide informed consent form (ICF), be compliant with study procedures such as eDiary completion, be compliant with background anti-seizure medication (ASM) and Investigational Medicinal Product (IMP) intake.
- •Diagnosis of epilepsy with Focal-onset seizures (FOS) with or without secondary generalization according to the International League Against Epilepsy Classification of epileptic seizures.
- •On stable doses of ASM for at least 4 weeks prior to screening. List of allowed ASM medications are provided in Appendix 18.
- •Confirmed drug-resistant FOS despite 1-3 stable ASM with at least 6 seizures during the 8 week observational period
- •Patients who have Vagal Nerve Stimulator (VNS) must have stable settings > 3 months prior to screening and expected to remain unchanged during the duration of the study
- •Females of childbearing potential, if not abstinent, should use a highly effective contraception, started 60 days prior to study entry and 30 days after end of study drug administration: Combined (Estrogen and progesterone containing) hormonal contraception associated with inhibition of ovulation: -Oral -Intravaginal -Transdermal; Progesterone-only hormonal contraception associated with inhibition of ovulation -Oral -Injectable -Implantable; Intrauterine device; Intrauterine hormone-releasing system; Bilateral tubal occlusion; Vasectomized partner; Sexual abstinence. See Appendix 18.1 for additional details.
- •Females of non-childbearing potential: either surgically sterilized (e.g. bilateral tubal ligation), had undergone hysterectomy or is at least 1 year postmenopausal (amenorrhea duration of at least 12 months)
- •Sexually active males with partner of childbearing potential commit to use an acceptable method of birth control consistently and correctly (oral, transdermal, systemic or implant contraception birth control, intrauterine devices) for 90 days after the last study drug administration.
排除标准
- •Presence of primary generalized epilepsies or seizures, such as absences, myoclonic epilepsies, Lennox-Gastaut syndrome.
- •Laboratory values at screening: • Platelets < 100,000/mm3 • Absolute neutrophil count < 1500/mm3 • Haemoglobin < 10.0g/dL • Aspartate aminotransferase or alanine aminotransferase > 3x upper limit of normal • Estimated Glomerular Filtration Rate < 80
- •History of status epilepticus in the past 3 months prior to screening.
- •Seizure clusters where individual seizures cannot be counted.
- •History of non-epileptic seizures.
- •Evidence of clinically significant disease (cardiac, respiratory, gastrointestinal, hepatic, hematologic or renal disease, neoplastic malignancies etc.) that in the opinion of the investigator could affect the subject's safety or trial conduct.
- •Neurodegenerative and other progressive neurological disorders.
- •Diagnosis of active psychiatric disease, except depressed subjects on stable doses of selective serotonin reuptake inhibitors/serotonin and norepinephrine reuptake inhibitors for at least 12 weeks prior to screening.
- •History of prior suicide attempt or imminent risk of self-harm based on investigator’s judgment or with a “yes” answer on item 4 or 5 on the Columbia Suicide Severity Rating Scale (CSSR-S).
- •History of drug abuse as defined by Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-V) and/or positive drug screening other than prescribed drugs.
- •Body weight < 50kg.
- •Alcohol abuse as per Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-V) in the past year.
- •Current use of levetiracetam.
- •Positive for hepatitis C virus (HCV) or hepatitis B surface antigen (HBsAg) or Human Immunodeficiency Virus (HIV) infection at screening.
- •Subjects presenting symptoms of coronavirus disease COVID-
- •Known allergic reaction or intolerance to levetiracetam or other pyrrolidone derivatives or to any of the excipients.
- •Participation in a study involving administration of an investigational product within one month prior to screening or within five half-lives of the previous study investigational compound, whichever is longer.
- •Women who are currently pregnant, who intend to become pregnant during the study, or who are breastfeeding.
- •Subjects with a diagnosis of Congenital Short QT Syndrome (SQTS). Subjects with a family history of Congenital Short QT Syndrome (SQTS) or family history of sudden death of unknown cause.
- •The corrected QT interval by Fredericia (QTcF) ≥ 450 msec in male and 470 msec in female subjects.
结局指标
主要结局
Percent change from baseline* in FOS frequency per week over the 12 week double-blind period.
Percent change from baseline* in FOS frequency per week over the 12 week double-blind period.
次要结局
- Change from baseline* in absolute FOS over the 12 week double-blind period.
- Proportion of subjects with at least 50% reduction from baseline* in total seizure frequency per week over the 12 week double-blind period.
- Proportion of subjects with at least 50% reduction from baseline* in total seizures over the 12 week double-blind period.
- Number of days free of FOS over the treatment period of 12 weeks.
- Response in Weekly FOS Frequency (Categorized Into 6 Categories According to Reduction) Over the Treatment Period of 12 Weeks).
- Change in the Quality of Life in Epilepsy (QoLIE-31) scale score (patients ≥18 years) and QoLIE- AD-48 (age <18 years) over the study period.
- Improving medication compliance and patient satisfaction with the treatment over the study period.
研究者
Abdelkarim Bendarraz
Scientific
Neuraxpharm Pharmaceuticals S.L.
研究点 (41)
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