NL-OMON48938已完成3 期
A Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotrophic Lateral Sclerosis - ORARIALS-01
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 19
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. Capable of- and willing to- provide written informed consent and comply with
- •trial procedures.
- •2. Subject is male or female *18 years of age.
- •3. Subject meets revised El Escorial criteria for clinically possible,
- •clinically probable / clinically probable ALS laboratory-supported, clinically
- •definite ALS or clinically definite familial ALS laboratory-supported.
- •4. 18 months or less since first appearance of weakness (e.g. limb weakness,
- •dysarthria, dysphagia, shortness of breath).
- •5. ALSFRS-R *35 and erect (seated) SVC % predicted * 70% at Screening.
- •6. Able and willing to travel to the site, and in the investigator*s opinion is
- •likely to attend visits for at least 24 weeks.
- •7. All sexually active female subjects of child-bearing potential
- •(postmenarchal)* must agree not to intend to become pregnant and use a highly
- •effective method of contraception** during the trial through 1 month after the
- •last dose of trial medication. If the subject is a sexually active male with
- •female partners of child-bearing potential (postmenarchal) he must use a condom
- •with or without spermicide in addition to the birth control used by their
- •partners during the trial until 3 months after the last dose of trial
- •medication.
- •8. Stable dose of riluzole (50 mg twice daily) for a minimum of 14 days prior
- •to Day 1 (Baseline),or has not taken it for 14 days prior to Day 1.
排除标准
- •1. Tracheostomy or use of non-invasive ventilation for more than 2 hours during
- •waking hours at the time of Screening and Baseline visits.
- •2. Pregnant or breast-feeding.
- •3. Current or anticipated use of diaphragmatic pacing during the trial.
- •4. Exposure to any investigational treatment within 4 weeks or <5 half-lives of
- •the Screening visit, whichever is longest and/or advanced therapy medicinal
- •product (ATMP), i.e. treatments based on genes, cells or tissues and/or
- •participated in any prior ALS clinical trial receiving active drug treatment
- •(with the exception described in exclusion criterion 5).
- •5. Treatment with edaravone within 4 weeks of the Baseline visit. However, up
- •to 18 subjects on stable (i.e. minimum 6 months*) treatment with edaravone and
- •who otherwise fulfil the eligibility criteria are planned for enrolment
- •(limited to countries where edaravone has a marketing authorisation for
- •treatment of ALS).
- •6. Any of the following medically significant conditions:
- •a) Neurological impairment/dysfunction or unstable psychiatric illness that in
- •the investigator*s opinion is likely to interfere with assessment of ALS
- •disease progression.
- •b) Clinically significant unstable medical condition other than ALS, which
- •would present a risk to a subject to participate in the trial
- •c) Presence of dementia that impairs the ability of the subject to provide
- •informed consent, according to the PI decision.
- •d) Known or suspected allergy or intolerance to the IMP (arimoclomol or
- •constituents);
- •e) Chronic infection particularly HIV or Hepatitis B or C.
- •f) Clinically significant renal or hepatic disease
- •g) Aspartate aminotransferase and/or alanine aminotransferase, and/or lactate
- •dehydrogenase *3 times the upper limit of normal [ULN], bilirubin*2 times the
- •ULN, or creatinine *1.5 times the ULN). Laboratory tests may be repeated once
- •at Screening. Reasons to repeat laboratory tests may include that the
- •medication causing laboratory abnormality was suspended, any other suspected
- •cause may no longer exist, or to rule out laboratory error.
- •h) Cancer that is currently under active treatment or is likely to require
- •treatment during the trial that may alter the subject*s function and thereby
- •interfere with assessment of ALS disease progression.
- •i) Any other condition that in the investigator*s opinion would present a risk
- •to a subject to participate in the trial, interfere with the assessment of
- •safety or has an increased risk of causing death during the trial.
- •* Non child-bearing potential is defined as post-menopausal (minimum of 12
- •months with no menses and follicle-stimulating hormone in the post-menopausal
- •range) or sterilisation (hysterectomy, oophorectomy, or bilateral tubal
- •ligation).** Highly effective methods of contraception include combined
- •(oestrogen and progestogen containing) hormonal contraception associated with
- •inhibition of ovulation (oral, intravaginal, or transdermal); progestogen-only
- •hormonal contraception associated with inhibition of ovulation (oral,
- •injectable, or implantable); intrauterine device; intrauterine
- •hormone-releasing system; bilateral tubal occlusion; and vasectomised
- •partner.According to the recommendations from the Clinical Trial Facilitation
- •Group (CTFG, 2014), sexual abstinence is considered a highly effective birth
- •control method only if
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