EUCTR2018-002485-39-ES进行中（未招募）1 期
A PHASE 2, PROSPECTIVE, INTERVENTIONAL, OPEN-LABEL, MULTI-SITE, EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY AND TOLERABILITY OF TAK-935 (OV935) AS ADJUNCTIVE THERAPY IN PATIENTS WITH RARE EPILEPSY (ENDYMION)
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
入选标准
- •1) Patients 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 patient 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 patient has the potential to benefit from the administration of TAK-
- •3) The patient provides written informed consent, or the patient’s legal representative (parent or legal guardian) provides written
- •informed consent and the patient provides assent, before any study procedures are performed.
- •4) The patient and legal representative (parent or guardian) are willing to comply with all study requirements.
- •5) Sexually active female patients of childbearing potential (defined as first menarche) must agree to use a
- •highly effective method of birth control during the study and for 30 days following the last dose of study. Highly effective contraceptive methods are as follows:
- •a) Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of
- •? Intravaginal
- •? Transdermal
- •b) Progestogen-only hormonal contraception associated with inhibition of ovulation:
- •? Injectable
- •? Implantable
- •c) Intrauterine device
- •d) Intrauterine hormone-releasing system
- •e) Bilateral tubal occlusion
- •f) Vasectomized partner
- •g) Sexual abstinence
- •Sexually active male patients (post-pubertal unless permanently sterilized by bilateral orchidectomy) must
- •agree to use male contraception (condom) during the study and for a minimum of 90 days following the
- •last dose of study drug. Male patients must also not donate sperm during the Screening and Treatment
- •Periods and for at least 90 days after the last dose of study drug.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 165
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 11
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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. Patient is currently pregnant or breastfeeding or is planning to become pregnant during the study or
- •within 90 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
研究者
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