2023-508413-16-00招募中2 期
OXYTAHANE - Oxygen therapy: Acute Treatment for paroxysmal dystonic or plegic attacks in alternating hemiplegia of childhood
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- The primary outcome will be the proportion of motor attacks stopped 30 minutes after the beginning of motor symptoms over 5 weeks.
研究概览
简要总结
The aim of the study is to assess the effect of high-flow oxygen administration (against placebo) as an acute treatment of dystonic and plegic attacks
入排标准
- 年龄范围
- 0 years 至 65+ years（0-17 Years, 65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Age > 1 year old
- •Patients able to administrate high-flow oxygen through a non rebreathing facial mask, either alone or with assistance
- •Patients with a diagnosis of AHC caused by ATP1A3 mutations presenting at least one dystonic or plegic attack per week lasting more than 30 minutes
- •Absence of long-term treatment or long-term treatment stable over the last month and during the duration of the trial
- •Patients able to give written informed consent
- •Affiliation to social insurance
排除标准
- •Inability for the patients and/or caregivers to follow the protocol (inability to read or understand the instructions, no access to smartphone or computer to fill the informatics patient’s form)
- •Patients with severe or uncontrolled obstructive or restrictive chronic respiratory disease (asthma, COPD, obesity, neuromuscular disease), acute systemic aggression (acute coronary syndrome, stroke, sepsis, head trauma) or congenital cardiopathy with a risk of hypercapnia following oxygen administration
- •Women that are pregnant (a negative pregnancy test is required for inclusion) or breath feeding
- •Patients involved in an other clinical trial
结局指标
主要结局
The primary outcome will be the proportion of motor attacks stopped 30 minutes after the beginning of motor symptoms over 5 weeks.
The primary outcome will be the proportion of motor attacks stopped 30 minutes after the beginning of motor symptoms over 5 weeks.
次要结局
未报告次要终点
研究者
Pr Flamand-Roze
Scientific
Assistance Publique Hopitaux De Paris
研究点 (2)
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