EUCTR2022-003050-32-PT进行中（未招募）1 期
A multicenter, open-label extension study to investigate the long-term safety of FAB122 in patients with Amyotrophic Lateral Sclerosis - ADOREXT
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 225
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Patients who meet all of the following criteria, will be eligible for the study:
- •1.who completed the full study period in the main ADORE study (FAB122-CT-2001; (EudraCT number 2020-003376-40);
- •2.whom the investigator has no concern and judges tolerable for receiving treatment with FAB122 from a risk and benefit point of view;
- •3.a female subject should not be able to become pregnant up to 30 days after the last dose of FAB122 and needs to meet at least one of the following criteria:
- •-female subject who is not of reproductive potential is eligible without requiring the use of contraception. A woman is considered not having childbearing potential when becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
- •-female who is of reproductive potential and has a negative pregnancy test at baseline and is non-lactating. A female subject who is of reproductive potential agrees to use (or have their partner use) adequate birth control methods starting from the time of consent through 30 days after the last dose of study therapy. Longer periods of birth control may be required per local requirements. Acceptable methods of birth control include combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device in place for =3 months, intrauterine hormone-releasing system, bilateral tubal occlusion or vasectomised partner.
- •4.a male patient must:
- •-agree he will not donate sperm during the period he will be using FAB122, AND use a condom during sexual intercourse with pregnant or non-pregnant women of childbearing potential (WOCBP) partner even if he is vasectomized and until 104 days after the last dose,
- •-in addition WOCBP partner of the male patient must use the following acceptable methods of birth control during the study and until 104 days after the last dose: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device in place for =3 months, intrauterine hormone-releasing system, bilateral tubal occlusion or vasectomised partner;
- •5.providing informed consent.
- •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 147
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 78
排除标准
- •Patients who meet any of the following criteria, will not be eligible for the study:
- •1. Patient who has a medical condition (e.g. cardiac, pulmonary, gastrointestinal, musculoskeletal, or psychiatric illness) or personal circumstances which, in the opinion of the investigator, will make initiation or continuation of treatment with FAB122 not tolerable for them from a risk and benefit point of view.
- •2. Patient who discontinued study drug prematurely in the double-blind phase of the study (ADORE Study) for safety reasons.
- •3. Patient who has received any other investigational drug within the period between last visit of the main study and first visit of the extension study (i.e. another trial, managed access program, open label extension or early access program)
- •4. - History of known hypersensitivity to edaravone or to any of the excipients.
- •For patients who do not take FAB122 but are only followed up by phone, only inclusion criteria #1 and #5 will apply.
研究者
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