CTIS2022-502281-25-00招募中1 期
A Randomized, Double-blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Focal-Onset Seizures - XPF-010-302
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 416
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Subject is properly informed of the nature and risks of the study and gives informed consent in writing prior to entering the study., Subject with an implanted vagal nerve stimulator, deep brain stimulation, or responsive neurostimulator system will be allowed to participate in the study if the stimulator, stimulation, or neurostimulator system is present for >1 year prior to entry into the DBP, and the battery does not need to be replaced during the DBP. The stimulation parameters must have been kept constant for >3 months prior to Visit 1 and for the duration of the study., Subject is able to participate for the full term of the study., Subject has a diagnosis (=2 years) of focal epilepsy according to the International League Against Epilepsy 2017 classification criteria. Subject must have had adequate trials of at least 2 ASMs, which were given (and tolerated) at adequate therapeutic doses, without achieving sustained seizure freedom., Subject is on a stable dose of 1 to 3 allowable current ASMs for at least 1 month prior to screening (Visit 1), during screening/baseline, and throughout the DBP., Subject is able to keep accurate seizure diaries, Subject is =18 years of age with a BMI =40 kg/m2 at Visit 1., Subject has prior neuroimaging (CT or MRI) within the last 10 years and documentation is available., Subject is willing to comply with the contraception requirements as defined in Protocol, Male subjects must agree not to donate sperm from the time of the first administration of study drug until 3 months after the last dose of study drug. Female subjects must agree not to donate ova from the time of the first administration of study drug until 6 months after the last dose of study drug.
排除标准
- •Subject has previously documented electroencephalogram which shows any pattern not consistent with focal etiology of seizures., Subject has status epilepticus within the last 12 months prior to Visit 1., Subject has history of neurosurgery for seizures <1 year prior to Visit 1, or radiosurgery <2 years prior to enrollment., Subject has schizophrenia and other psychotic disorders (eg, schizophreniform disorder, schizoaffective disorder, psychosis not otherwise specified), bipolar disorder, and/or obsessive-compulsive disorder, or other serious mental health disorders including uncontrolled unipolar major depression where changes in pharmacotherapy are needed or anticipated during the study, Subject had an active suicidal plan/intent in the past 6 months, history of suicide attempt in the last 2 years, or more than 1 lifetime suicide attempt., Subject has history or presence of any significant medical or surgical condition or uncontrolled medical illness including, but not limited to, hematologic, cardiovascular, pulmonary, severe renal impairment (<30 mL/min CLCR), gastrointestinal, endocrine, hepatic (including those with mild, moderate, or severe hepatic impairment, defined as Child Pugh score >5), or urogenital systems, or other conditions that would place the subject at increased risk or prevent adherence to the protocol, as determined by the investigator., Subject has ALT or AST levels >3-times the ULN at Visit 1., Subject has any clinically significant laboratory abnormalities or clinically significant abnormalities on prestudy physical examination, vital signs, or ECG that, in the judgment of the investigator, indicate a medical problem that would preclude study participation including but not limited to: a. History or presence of long QT syndrome; QTcF >450 msec at baseline; family history of sudden death of unknown cause., Subject has history of skin or retinal pigment epithelium abnormalities or maculopathy caused by ezogabine/retigabine, Subject has history of cancer within the past 2 years, with the exception of appropriately treated basal cell or squamous cell carcinoma., Female subject who is pregnant, breastfeeding, or planning to become pregnant from the first administration of study drug until 6 months after the last dose of study drug, Subject has history of focal aware non-motor seizures only, Subject has any previous exposure to XEN1101., Subject has exposure to any other investigational drug or device within 5 half lives or 30 days prior to Visit 1, whichever is longer., Use of vigabatrin in the last 5 years without stable visual fields tested twice over the 12 months after the last dose of vigabatrin (subjects stopping vigabatrin more than 5 years prior to screening must have no vigabatrin-related visual field abnormalities confirmed by examination within the past 6 months; concomitant use of vigabatrin is not allowed)., Concomitant medication restrictions: If felbamate is used as a concomitant ASM, subject must have been on felbamate for at least 2 years, with a stable dose for 2 months (or no less than 49 days) prior to Visit 1. Subject must not have a history of WBC count below 2500/µL (2.50 × 109/L), platelets below 100,000/mm3 (100 × 109/L), liver function tests >3-times the ULN, or other indication of hepatic or bone marrow dysfunction while receiving felbamate. If subject received felbamate in the past, it must have been discontinued 2 months (or no less than 49 days) prior to screening; systemic use of a s
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