EUCTR2015-005810-31-FR进行中（未招募）1 期
Effect of MD1003 in amyotrophic lateral sclerosis: a randomized, double blind placebo controlled study - MD1003-ALS
MEDDAY PHARMACEUTICALS0 个研究点目标入组 30 人开始时间: 2016年10月24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
- 30
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
- •-Age: 25 to 80 years, inclusive.
- •-Male or female subjects with probable or confirmed ALS (revised international El Escorial criteria, Forbes et al., 2001).
- •-Patients presenting first motor deficits due to ALS for a maximum of three years at the first consultation in an ALS centre.
- •-Patients monitored for at least 6 months in an ALS centre or for whom the previous monitoring parameters are available (excepted for MIP and SNIP).
- •-Patients who have lost at least 5 points on the ALSFRS-R during the last 12 months or at least 2 points during the preceding 6 months
- •-Patients who have been treated with riluzole for at least 3 months at a stable dose. In case of intolerance to this product or refusal for this treatment, patients who have not been treated with riluzole for at least 1 month.
- •-For patients with spinal form (onset of the disease affecting limbs) or respiratory form, slow vital capacity > 60% of predicted value.
- •-For patients with a bulbar form, slow vital capacity > 60% of theoretical value or, if spirometry not assessable (severe bulbar disability), patient should not have significant abnormality in both nocturnal capnography and nocturnal oximetry (median pCO2 < 52 mmHg, SaO2 < 90% less than 5% of the time during night) less than 3 months prior inclusion.
- •-Patients who are willing to give written consent (or oral consent in the presence of a trusted person if the patient is no longer able to write)
- •-Patients likely to be able to participate in all scheduled evaluation and complete all required study procedures (except for spirometry in bulbar patients with severe disability).
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •-Patients on non-invasive ventilation for respiratory insufficiency due to ALS for more than 10 hours a day
- •-Patients with an ALSFRS-R score at inclusion of < 20 (maximum score without disability = 48)
- •-Patients who have lost less than 5 points on the ALSFRS-R during the last year or less than 2 points during the preceding 6 months
- •-Patients with a gastrostomy
- •-Patients who have lost more than 15% of their ideal weight
- •-Patient with dyspnoea at rest or with the least effort (score < 3 on the dyspnoea item of the ALSFRS-R)
- •-Patients with dementia
- •-Patient with severe or rapidly progressive form of ALS for whom the investigator estimates the life expectancy less than 3 months
- •-Patients with another progressive disease that has not been stabilized at the time of inclusion
- •-Patients with cancer, except basal cell carcinoma, for less than 5 years, or who require continuous treatment for cancer even if it is older
- •-Pregnant women.
- •-Subject who are not covered by a social security scheme.
- •-Subject under temporary or permanent Judicial Protection.
- •-Contraception: Both male subjects, and female subjects who are not either surgically sterile (tubal ligation/obstruction or removal of ovaries or uterus) or post-menopausal (no spontaneous menstrual periods for at least one year confirmed by a negative hormone panel), must commit to using two highly effective method of birth control for the duration of the study and for two months after the treatment termination.
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