EUCTR2019-000374-39-PL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
适应症
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. Subject completed ORARIALS-01 while on treatment with IMP , where
- •on treatment is defined as having taken the last dose of IMP within 2
- •weeks of the last End of Trial visit of the blinded ORARIALS-01 (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 hysterectomy 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
- •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
- •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.
研究者
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