EUCTR2018-002485-39-PL进行中（未招募）1 期
A Phase 2, Prospective, Interventional, Open-Label, Multisite, Extension Study To Assess the Long-Term Safety and Tolerability of Soticlestat (TAK-935) as Adjunctive Therapy in Subjects With Developmental Epileptic Encephalopathies Including Dravet Syndrome, Lennox Gastaut Syndrome, CDKL5 Deficiency Disorder, and Chromosome 15 Duplication Syndrome (ENDYMION 1).
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 176
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
- 性别
- All
入选标准
- •1) Subjects must have participated in a previous TAK-935 study and meet one of the following conditions:
- •Successfully completed a TAK-935 clinical study.
- •Received at least 10 weeks of treatment (combined Dose Optimization and Maintenance Period) with the study drug in a TAK-935 clinical study and the subjects did not have a serious or severe AE that, in the investigator's or Sponsor's opinion, was related to the study drug and would make it unsafe for the patient to continue receiving the study drug.
- •2) In the opinion of the investigator, the subject has the potential to benefit from the administration of TAK935.
- •3) The subject provides written informed consent, or the subject's legal representative (parent or legal guardian) provides written informed consent and the subject provides assent, before any study procedures are performed.
- •4)The subject and subject's legal representative (ie, parent or guardian [as applicable]) are willing to comply with all study requirements.
- •5) From signing of informed consent, throughout the duration of the study, and for 30 days after last dose of study drug, female patients of childbearing potential* who are sexually active with a nonsterilized male partner** must agree to use a highly effective method of contraception (from the list below). In addition, they must not donate ova during this period.
- •* Females NOT of childbearing potential are defined as those who are prior to first menarche or who have been surgically sterilized (hysterectomy, bilateral oophorectomy, or tubal ligation) or who are postmenopausal (eg, defined as =1 year since last regular menses with a follicle stimulating hormone level >40 IU/L or =5 years since last regular menses, confirmed before any study drug is administered).
- •**Sterilized males should be =1 year postvasectomy and have confirmed that they have obtained documentation of the absence of sperm in the ejaculate.
- •A highly effective method of contraception is defined as one that has no higher than a 1% failure rate per year when used consistently and correctly. In this study, the only acceptable methods of contraception are as follows:
- •a. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
- •Intravaginal
- •Transdermal
- •b. Progestogen-only hormonal contraception associated with inhibition of ovulation:
- •Injectable
- •Implantable
- •c. Double-barrier methods (each time the patient has intercourse):
- •Sponge (plus spermicidal cream or jelly) PLUS male condom with or without spermicidal cream or jelly.
- •Cap (plus spermicidal cream or jelly) PLUS male condom with or without spermicidal cream or jelly.
- •Diaphragm (plus spermicidal cream or jelly) PLUS male condom with or without spermicidal cream or jelly.
- •d. Intrauterine device (Copper T PLUS condom)
- •e. Intrauterine hormone-releasing system
- •f. Sterilization:
- •Bilateral tubal occlusion
- •Vasectomized partner (provided that the partner is the sole sexual partner of the patient and the absence of sperm in the ejaculate has been confirmed)
- •g. Sexual abstinence, if it is the preferred and usual lifestyle of the patient, will be considered an acceptable method of contraception on a case-by-case basis upon prior approval by the medical monitor. Patients practicing abstinence as a method of contraception must refrain from heterosexual intercourse throughout the duration of the study and for 30 days after last dose of study drug.
- •From signing of informed consent,
排除标准
- •1. Clinically significant disease, that, in the investigator’s opinion, precludes study participation
- •2. Enrollment in any other clinical trial involving an investigational drug, device, or treatment in the past 90 days (with the exception of an antecedent study involving TAK-935)
- •3. Subject is currently pregnant or breastfeeding or is planning to become pregnant during the study or
- •within 30 days of the last study drug administration
- •4. Suicide attempt within the last year, at significant risk of suicide (either in the opinion of the investigator or defined as ‘yes’ to suicidal ideation question 4 or 5 on the Columbia- Suicide Severity Rating Scale [C-SSRS] at Screening) or appearing suicidal per investigator judgment
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