CTIS2022-502286-16-00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 Primary Generalized Tonic-Clonic Seizures (X-ACKT) - XPF-010-303
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 191
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
- 0 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 or assent in writing prior to entering the study. Legal representatives/Parents will provide consent for minors to participate in the study, Subject is willing to comply with the contraception requirements, 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, Subject has a documented routine EEG within 5 years prior to Visit 1 or during the prerandomization period, Subject with an implanted vagal nerve, deep brain stimulator, or responsive neurostimulator system will be allowed to participate in the study if the stimulator was implanted at least 5 months prior to Visit 1, and the battery does not need to be replaced nor the stimulator parameters changed from 30 days 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 probable or possible PGTCS (with or without other subtypes of generalized seizures) for =1 year, in the setting of generalized epilepsy according to the International League Against Epilepsy 2017 classification criteria, and subject is approved by TESC., 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 =12 years of age, [CCI], and has a BMI =40 kg/m2 at Visit 1., 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 had onset of PGTCS before age 40 years, Subject has prior neuroimaging (CT or MRI) within the last 10 years (performed after the onset of seizures) and documentation is available., Subject must have had at least 3 PGTCS during the 8 weeks prior to Visit 1, verified by historical seizure diary or by reliable subject and/or caregiver report, in the opinion of the investigator.
排除标准
- •Subject has had status epilepticus within the 12 months prior to Visit 1., Subject has schizophrenia or other psychotic disorders (eg, schizophreniform disorder, schizoaffective disorder, psychosis not otherwise specified), bipolar disorder, obsessive-compulsive disorder, or another serious mental health disorder. Subject has 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 any previous exposure to XEN1101, 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 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 exposure to any other investigational drug or device within 5 half-lives or 30 days prior to Visit 1, whichever is longer., Subject has history of repetitive seizures within the 12-month period preceding Visit 1 where the individual seizures could not be counted., Subject has presence or history of a developmental and epileptic encephalopathy, including Lennox-Gastaut syndrome., 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 medications 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. Subjects must not have a history of WBC count below 2500/µL (2.50 × 10^9/L), platelets below 100,000/mm3 (100 × 10^9/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; [CCI], Subject has had multiple drug allergies or a severe drug reaction to an ASM(s), including dermatological (eg, Stevens-Johnson syndrome), hematological, or organ toxicity reactions., Subject has a history of nonepileptic psychogenic seizures., Subject has a concomitant diagnosis of Focal-onset Seizures., Subject has seizures secondary to drug or alcohol use, ongoing infection, neoplasia, demyelinating disease, degenerative neurological disease, metabolic illness, progressive structural
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