EUCTR2008-008208-42-GB进行中（未招募）1 期
A Randomised, Double-Blind Placebo-Controlled Pilot Study Assessing the Safety and Tolerability of Arimoclomol in Adult with Sporadic Inclusion Body Myositis - Arimoclomol for Inclusion Body Myositis
CL - The Joint UCLH/UCL Comprehensive Biomedical Research Unit0 个研究点目标入组 24 人开始时间: 2009年5月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
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
入选标准
- •1. Meet the diagnostic criteria for definite or probable IBM (Griggs 1995)
- •2. Muscle function adequate for quantitative muscle testing. At least 8 of the following 16 muscle groups must have a MMT muscle grade greater or equal 3- or greater on the modified Medical Research Council Scale: Shoulder abductors, Elbow Flexors, Elbow Extensors, Wrist Flexors, Knee Extensors, Ankle Dorsiflexors, Knee Flexors, Neck Flexors (unilateral) and Neck Extensors (unilateral).
- •3. Age>50 years
- •4. Women must be post-menopausal (no menses in > 12 months) or status - post hysterectomy
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Presence of any one of the following medical conditions: diabetes mellitus or patients taking anti-diabetic medications, chronic infection, chronic renal insufficiency, cancer other than skin cancer less than 5 years previously, multiple sclerosis or prior episode of central nervous system demyelination, or other chronic serious medical illnesses
- •2. Presence of any of the following on routine blood screening: WBC<3000/cm3, platelets<100,000/cm3, hematocrit < 30 %, urea > 10 millimoles/litre, creatinne > 150 micromoles/litre, symptomatic liver disease with serum albumin < 30g/L, prothrombin time or activated partial thromboplastin time > upper range of control values
- •3. Currently taking Riluzole
- •4. Women who are pregnant or lactating
- •5. History of non-compliance with other therapies
- •6. Coexistence of other neuromuscular disease
- •7. Drug or alcohol abuse within last 3 months
- •8. Inability to give informed consent
- •9. Known bleeding disorder
- •10. Use of potentially renal-toxic drugs
- •11. Prior difficulties with local anesthetic
研究者
相似试验
进行中（未招募）
1 期
A randomized double-blind placebo-controlled, pilot trial of intravenous plasma-purified alpha-1 antitrypsin for severe COVID-19 illness.EUCTR2020-001391-15-IERoyal College of Surgeons Ireland36
招募中
1 期
A clinical trial conducted to determine the safety and tolerability of ORE1001 in patient suffering with Ulcerative Colitis.CTRI/2010/091/000097ORE Pharmaceuticals Ltd.50
进行中（未招募）
不适用
A Randomized, double-blind, placebo-controlled pilot study of KB001 in mechanically-ventilated patients colonized with pseudomonas aeruginosaEUCTR2007-006764-29-FRKaloBios Pharmaceuticals, Inc.
已完成
1 期
To study the effect of Ashwagandha extract on MemoryCTRI/2023/03/050974Arjuna Natural Private Limited,40
进行中（未招募）
1 期
Passion flower and stressSince only healthy volunteers will be included in this study, there is no medical condition to be examined. The indication for PASCOFLAIR® is nervous restlessness, a subclinical state of stress-sensitivity.EUCTR2011-006129-17-DEPASCOE Pharmazeutische Präparate GmbH60