JPRN-UMIN000025872已完成2 期
Placebo controlled double blind randomized Phase 2 clinical trial of sodium pyruvate on lactic acidosis associated with mitochondrial disorders (Leigh syndrome) - Placebo controlled double blind randomized Phase 2 clinical trial of sodium pyruvate on lactic acidosis associated with mitochondrial disorders (Leigh syndrome)
Japan Agency of Medical Research and Development0 个研究点目标入组 10 人开始时间: 2017年2月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
nfortunately, data obtained by the clinical trials could not prove the efficacy overall, though there are several patients with perfect improvement by clinical rating scales. After the strategy consultation to PMDA on October 18, 2018, we decided to terminate the SP project.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2years-old 至 30years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) patients who is not evaluated by this protocol of the clinical trial 2)severe unconsciousness 3)sepsis 4)renal dysfunction by eGFR lower than 60 mL/min/1.73m2 5)heart failure (EF<40%) 6)status epileptics 7)pregnant 8)allergy against the sodium pyruvate 9)enrolled to the other clinical trial 24 weeks before this trial 10)patient who cannot evaluate the muscle activity by device 11)patients who are not recommended by the doctor
研究者
相似试验
已完成
不适用
Placebo controlled double blind randomized Phase II Clinical Trial of sodium pyruvate on lactic acidosis associated with mitochondrial disorders (MELAS/MELA)MELAS/MELAJPRN-UMIN000025772Japan Agency of Medical Research and Development15
尚未招募
2 期
Clinical Safety & Efficacy Evaluation of Botanical Ingredient Formulation with Special Reference to Menstrual Irregularities and Wellbeing of Women.CTRI/2023/07/055457SARVOTHAM CARE LIMITED
尚未招募
2 期
A study of the safety and efficacy of 7 days treatment with BIT225 in patients with COVID-19, compared to placebo, including measurement of antiviral activity, clinical recovery and immune biomarkers.COVID-19Infection - Other infectious diseasesACTRN12623000035628Biotron Limited60
进行中（未招募）
1 期
Efficacy and Safety of Belimumab in the Treatment of IgA NephropathyImmunoglobulin A (IgA) nephropathyMedDRA version: 20.0 Level: PT Classification code 10021263 Term: IgA nephropathy System Organ Class: 10038359 - Renal and urinary disordersEUCTR2017-004366-10-GBniversity of Leicester21
进行中（未招募）
不适用
Double Blind Placebo Controlled Clinical Investigation into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients with Severe Pulmonary Arterial HypertensioYHA Class III and IV patients with severe Pulmonary Arterial HypertensioMedDRA version: 14.1Level: PTClassification code 10037400Term: Pulmonary hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2004-003236-59-ITnited Therapeutics Corporation220