EUCTR2017-004459-21-IT进行中（未招募）1 期
Colchicine for Amyotrophic Lateral Sclerosis: a phase II, randomized, double blind, placebo controlled, multicenter clinical trial - Co-ALS
AZIENDA OSPEDALIERO-UNIVERSITARIA POLICLINICO DI MODENA0 个研究点目标入组 54 人开始时间: 2018年11月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 54
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
- •- Patients diagnosed with a laboratory supported , clinically probable” or definite” amyotrophic lateral sclerosis according to the Revised El Escorial criteria (Brooks, 2000)
- •- Sporadic ALS
- •- ALS phenotypes: classic or bulbar
- •- Female or male patients aged between 18 and 80 years old
- •- Disease duration from symptoms onset no longer than 18 months at the screening visit
- •- Patients treated with a stable dose of Riluzole (100 mg/day) for at least 30 days prior to screening
- •- Patients with a weight > 50 kg and a BMI =18
- •- Patients with a FVC (Forced Vital Capacity) equal or more than 65 % predicted normal value for gender, height, and age at the screening visit
- •- Patients able and willing to comply with study procedures as per protocol
- •- Patients able to understand, and capable of providing informed consent at screening visit prior to any protocol-specific procedures
- •- Use of highly effective contraception both for males and females
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 29
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •- Prior use of colchicine
- •- Prior allergy/sensitivity to colchicine
- •- Receiving colchicine or other anti-inflammatory drugs (such as corticosteroids, methotrexate, anti-neoplastic, Interleukin 1-1b antagonist, Tumor necrosis factor-alpha inhibitor)
- •- Receiving food or co-medications such as strong-moderate cytochrome P450 3A4 inhibitors that will result in elevated plasma level of colchicine
- •- Inflammatory disorders (SLE, Rheumatoid arthritis, connective tissue disorder) or chronic infections (HIV, hepatitis B or C infection) or significant history of malignancy
- •- Severe renal (eGFR< 30ml/min/1.73m2), or liver failure or liver aminotransferase (ALT/AST > 2x Upper limit of normal)
- •- Existing blood dyscrasia (e.g., myelodysplasia)
- •- 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
- •- Patients who underwent non invasive ventilation, tracheotomy and /or gastrostomy
- •- Women who are pregnant or breastfeeding
- •- Participation in pharmacological studies within the last 30 days before screening
- •- Patients with known pathogenic mutations (SOD1, TARDBP, FUS, C9ORF72)
- •- Patients with familial ALS defined as presence of at least one first degree family member (parents/son/daughter/brother/sister) affected by ALS
- •- Patients with the following ALS phenotypes: flail arm, flail leg, UMN-p, respiratory, PLS, progressive muscular atrophy
研究者
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