EUCTR2019-000374-39-NL进行中（未招募）1 期
Open-label, Non-randomised Extension Trial to Assess the Long-Term Safety and Efficacy of 1200 mg/day Arimoclomol 400 mg Three Times a Day (t.i.d.) in Subjects with Amyotrophic Lateral Sclerosis (ALS) who have Completed the ORARIALS-01 Trial
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 231
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. Subject is able to comprehend and is willing to provide written informed consent and is capable and willing to comply with trial procedures or in the circumstance that the subject is incompetent, informed consent/assent is provided in accordance with local regulation and/or procedures.
- •2. Subject has completed the ORARIALS-01 trial (i.e., met one of the surrogate survival endpoints of tracheostomy or PAV or has completed the 76 weeks randomised treatment period).
- •3. Subjects completed ORARIALS-01 while on treatment, where on treatment is defined as having taken the last dose of IMP within 2 weeks of the End of Trial visit. (whether at week 76 or prior)
- •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 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 71
排除标准
- •1. Known or suspected allergy or intolerance to the IMP (arimoclomol or
- •constituents).
- •2. Exposure to any other investigational treatment, advanced therapy
- •medicinal product(ATMP) or use of any other prohibited concomitant
- •medications.
- •3. Women who are lactating or pregnant, or men or women unwilling to
- •use a highly effective method of birth control if not surgically sterile
- •(defined as bilateral tubal ligation, bilateral oophorectomy, or orhysterectomy for women; vasectomy for men) for female participants until 4 weeks after last dose and for male participants until 3 months after last dose. Pre-menopausal women must have a negative pregnancy test prior to dosing with trial medication. Acceptable methods of birth control are:
- •a. Hormonal methods associated with inhibition of ovulation such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle (based on the subject's usual menstrual cycle period) before IMP administration.
- •b. Total abstinence from sexual intercourse since the last menses before IMP administration. (The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject. Periodic abstinence methods [calendar, symptothermal, post-ovulation methods] are not acceptable methods of contraception).
- •c. Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS).
- •4. Any of the following medically significant conditions:
- •a. Clinically significant renal or hepatic disease OR clinical laboratory assessment (results = 3 times the upper limit of normal [ULN] for aspartate aminotransferase and/or alanine aminotransferase, bilirubin = 2 times the ULN, or creatinine = 1.5 times the ULN).
- •b. Any new condition or worsening of existing condition which, in the opinion of the investigator would put the subject at undue risk.
- •5. Any serious adverse event or moderate/severe adverse event from the ORARIALS-01 trial which is ongoing at the time of transitioning to ORARIALS-02 and assessed as probably related to IMP.
- •6. Subjects who exceed 60 days from the End of Trial Visit date of the ORARIALS-01 trial at the time of enrolment.
研究者
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