EUCTR2019-003549-14-HU进行中（未招募）1 期
A PHASE 2B/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12 MONTH CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF MN-166 (IBUDILAST) FOLLOWED BY AN OPEN-LABEL EXTENSION IN SUBJECTS WITH AMYOTROPHIC LATERAL SCLEROSIS - COMBAT-ALS
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 230
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.Written or verbal informed consent is obtained and willing and able to comply with the protocol in the opinion of the Investigator;
- •2.Male or female subjects ages 18 to 80 years, inclusive;
- •3.Diagnosis of familial or sporadic ALS as defined by the El Escorial-Revised (2000) research diagnostic criteria for ALS [clinically definite, clinically probable, probable-laboratory-supported];
- •4.ALS onset of = 18 months from first clinical signs of weakness prior to Screening;
- •5.Documented ALS history of location of disease onset (i.e. bulbar onset, limb onset)
- •6.A total ALSFRS-R score of at least 35 overall at screening and:
- •a.No more than one of the 12 ALSFRS-R individual component items has a score of 1 or less at screening;
- •b.For limb onset subjects, ALSFRS-R score of = 3 on item #1 (speech), # 2 (salivation) and # 3 (swallowing);
- •7.ALSFRS-R score progression from onset of the first symptom of weakness to the ALSFRS-R score at Screening of > 0.3 points and < 1 point per month calculated as:
- •ALSFRS-R score at Screening minus ALSFRS-R score at onset of first symptom of weakness divided by number of months since onset of first symptom of weakness.
- •8.Slow vital capacity = 70% of predicted within at screening;
- •9.Currently on a stable dose of riluzole for at least 30 days prior to initiation of study drug;
- •10.Females of childbearing potential must use an effective method of contraception throughout the entire study period and for 30 days after study drug discontinuation;
- •11.Males should practice contraception (e.g. condom use and contraception by female partner) throughout the entire study period and for 30 days after study drug discontinuation;
- •12.Able to swallow study medication capsules;
- •13.Subject is willing and able to comply with the protocol assessments and visits, in the opinion of the Investigator;
- •14.Has no known allergies to the study drug or its excipients;
- •15.Has received pneumococcal vaccine within 6 years prior to starting clinical trial.
- •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 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1.Confirmed hepatic insufficiency or abnormal liver function (AST and/or ALT > 3 times the upper limit of normal);
- •2.Currently has a clinically significant psychiatric disorder or dementia which would preclude evaluation of symptoms;
- •3.Has a clinically significant medical condition (other than ALS) including the following: neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological disorder, or central nervous system infection that would pose a risk to the subject if they were to participate in the study or that might confound the results of the study;
- •4.Female subject is lactating, pregnant or planning pregnancy at Screening or Baseline;
- •5.History of malignancy < 5 years prior to signing the informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer;
- •6.ALSFRS-R score of = 1 on more than one item in the assessment’s individual components;
- •7.Resting pulse < 50 bpm, SA or AV block, uncontrolled hypertension, or repeated demonstration of a QTc interval of > 450 ms;
- •8.History of HIV (human immunodeficiency virus), clinically significant chronic hepatitis, or other active infection;
- •9.Current use or treated with Edaravone® = 3 months prior to signing consent;
- •10.Current use or treated with Nuedexta® = 3 months prior to signing consent;
- •11.Current use or treated with Methylcobalamin Vitamin B12 = 3 months prior to signing consent
- •12.History of stomach or intestinal surgery or any other condition that could interfere with or is judged by the Investigator to interfere with absorption, distribution, metabolism, or excretion of study drug;
- •13.History of alcohol or substance abuse (DSM-5 criteria) = 3 months prior to screening or alcohol or substance dependence (DSM-5 criteria) = 12 months prior to screening;
- •14.Poor peripheral venous access that will limit the ability to draw blood as judged by the Investigator;
- •15.Currently participating, or has participated in, a study with an investigational or marketed compound or device = 3 months prior to signing the informed consent;
- •16.Unable to cooperate with any study procedures, unlikely to adhere to the study procedures and keep appointments, in the opinion of the Investigator;
- •17.Use of tracheostomy, tracheostomy invasive mechanical ventilation [TIMV].
研究者
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