2026-526460-20-00招募中2 期
A RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, CLINICAL TRIAL OF COLCHICINE IN AMYOTROPHIC LATERAL SCLEROSIS (CO-ALS II)
Azienda Ospedaliero Universitaria Di Modena5 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2026年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 87
- 试验地点
- 5
- 主要终点
- Colchicine efficacy will be assessed by comparing the monthly decline in the ALSFRS-R score between the treatment and placebo groups over 30 weeks of treatment and 36 weeks of open-label extension
研究概览
简要总结
to determine whether colchicine, administered at a dosage of 0.005 mg/kg/day, can slow disease progression compared to placebo
研究设计
- 分配方式
- Na
- 主要目的
- Open Lable Extention
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with probable laboratory-supported, clinically probable, or definite ALS according to the Revised El Escorial criteria (Brooks, 2000) (both sporadic and familial forms)
- •Female or male patients aged between 18 and 80 years old
- •Disease duration from limb weakness or bulbar symptoms onset < or = 18 months at screening
- •Stable dose of Riluzole at 50 mg bid for at least 30 days prior to screening
- •BMI>17.5 Kg/m2
- •FVC≥60% of the predicted normal value for gender, height, and age at screening
- •Patients able to provide informed consent and willing to comply with study procedures
- •Use of highly effective contraception both for males and females
排除标准
- •Prior use or prior allergy/sensitivity to colchicine
- •Women who are pregnant or breastfeeding
- •Participation in other RCTs within the last 30 days before screening
- •Chronic use of colchicine or other anti-inflammatory drugs (e.g. corticosteroids, methotrexate, IL1-1b antagonist, TNF-alpha inhibitor)
- •Food or co-medications (e.g. strong CYP3A4 inhibitors) that will result in elevated plasma level of colchicine
- •Inflammatory/autoimmune disorders or chronic infections or malignancy
- •Severe renal or liver failure, blood dyscrasia or white blood cells<4,000/mm³, platelets count<100,000/mm³, hematocrit<30%
- •Severe comorbidities (heart, renal, liver failure), autoimmune diseases or any type of interstitial lung disease, with severity determined at the investigator’s clinical judgment
- •Patients with ALSFRS-R total score<28
- •Patients with invasive ventilation or non-invasive ventilation > 8 hours/day
- •Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
结局指标
主要结局
Colchicine efficacy will be assessed by comparing the monthly decline in the ALSFRS-R score between the treatment and placebo groups over 30 weeks of treatment and 36 weeks of open-label extension
Colchicine efficacy will be assessed by comparing the monthly decline in the ALSFRS-R score between the treatment and placebo groups over 30 weeks of treatment and 36 weeks of open-label extension
次要结局
- the average decline in ALSFRS-R scores in the two treatment arms from baseline to weeks 4, 8, 12, 18, 24, 30, 42, 54, and 66
- change in the Rasch-Built Overall Amyotrophic Lateral Sclerosis Disability Scale (ROADS) scores in the two treatment arms from baseline to weeks 8, 18, 30, 42, 54, and 66.
- overall survival in the two treatment arms, defined as the time from randomization to death or tracheostomy
- change in Forced vital capacity (FVC) in the two treatment arms from baseline to weeks 4, 8, 12, 18, 24, 30, 42, 54, and 66
- change in quality of life, assessed using the ALS Assessment Questionnaire-40 (ALSAQ-40) questionnaire in the two treatment arms from baseline to week 30 and 66
- changes in ALSFRS-R domain-specific subscores (e.g., bulbar and motor domains) in the two treatment arms from baseline to weeks 4, 8, 12, 18, 24, 30, 42, 54, and 66
- difference in the monthly decline in ALSFRS-R scores (delta FS) in the two treatment arms from treatment initiation to 30 weeks after treatment initiation (end of treatment) compared to the delta FS in the period from onset (considering a score of 48 for each patient at onset) to treatment initiation
研究者
Giulia Gianferrari
Scientific
Azienda Ospedaliero Universitaria Di Modena
研究点 (5)
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