EUCTR2018-003221-29-ES进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 as Adjunctive Therapy in Focal-onset Epilepsy.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- Be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study
- •- BMI <35 kg/m2
- •- Diagnosis (=2 years) of focal epilepsy according to the International League Against Epilepsy [ILAE] Classification of Epilepsy (2017)
- •- Treatment with a stable dose of 1 to 3 allowable current AEDs for at least one month prior to screening, during baseline, and throughout the duration of the study
- •- Must be willing to comply with the contraception requirements
- •- Able to keep accurate seizure diaries
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •- History of pseudoseizures, psychogenic seizures, primary generalized seizure, or focal aware non-motor seizures only
- •- Presence or previous history of Lennox-Gastaut syndrome
- •- Seizures secondary to other diseases or conditions
- •- History of repetitive seizures within the last 12 months where the individual seizures cannot be counted
- •- History of neurosurgery for seizures <1 year prior to enrollment, or radiosurgery <2 years prior to enrollment
- •- Schizophrenia and other psychotic disorders, or active suicidal plan/intent in the past 6 months, or a history of suicide attempt in the last 2 years, or more than 1 lifetime suicide attempt
- •- History or presence of any significant medical or surgical condition or uncontrolled medical illness at screening, or history of cancer within the past 2 years, with the exception of appropriately treated basal cell or squamous cell carcinoma
- •- Any clinically significant abnormalities on pre-study physical examination, vital signs, laboratory values or ECG indicating a medical problem that would preclude study participation
- •- Past use of vigabatrin without stable visual fields tested twice over the 12 months after the last dose of vigabatrin (concomitant use of vigabatrin is not allowed)
- •- If felbamate is used as a concomitant AED, patients must be taking it for at least 2 years, with a stable dose for =49 days and acceptable hematology and LFT values (or discontinued felbamate no less than 49 days) prior to Screening
- •- Have had multiple drug allergies or a severe drug reaction to an AED(s), including dermatological (e.g., Stevens-Johnson syndrome), hematological, or organ toxicity reactions
- •- Current use of a ketogenic diet
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