NL-OMON55065已完成3 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 - Arimoclomol in patients with amyotrophic lateral sclerosis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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, 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).
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 (see
- •section 6.8)
- •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. IUD or 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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