NL-OMON53712已完成3 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
- 3 期
- 状态
- 已完成
- 入组人数
- 18
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
- 年龄范围
- 18 至 99（—）
入选标准
- •All patients:
- •1. who completed the full study period in the main ADORE study
- •(FAB122-CT-2001);
- •2. whom the investigator has no concern and judges tolerable for the continued
- •treatment with FAB122 from a risk and benefit point of view;
- •3. a female subject should not be able to become pregnant 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
- •screening and 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 study and until 104 days after the
- •last dose, AND use a condom during sexual intercourse with pregnant or
- •non-pregnant women of childbearing potential (WOCBP) partner even if he is
- •vasectomized.
- •- 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.
排除标准
- •This study has no exclusion criteria. The study is an open-label extension of
- •an already existing study.
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