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临床试验/EUCTR2019-003676-39-NL
EUCTR2019-003676-39-NL进行中(未招募)1 期

Effects of sodium lactate infusion in patients with glucose transporter 1 deficiency syndrome (GLUT1DS)

未提供0 个研究点目标入组 4 人开始时间: 2020年6月9日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
4

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

  • In order to be eligible to participate in this study, a subject must meet all of the following criteria:
  • - Diagnosed with GLUT1DS and known in our center.
  • - Baseline characteristics include a high frequency of clinical seizures and epileptic discharges on EEG.
  • - History of trying ketogenic diet with good compliance but without beneficial effects.
  • - Age > 6 years.
  • - Informed consent.
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 4
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • A potential subject who meets any of the following criteria will be excluded from participation in this study:
  • - Additional medical condition or illness that impairs the patient’s ability to participate in the study (for example actual treatment of a malignancy, active infection, poorly controlled diabetes mellitus, hypertension, organ failure, clinically significant haematological or biochemical abnormalities).
  • - Elevated serum sodium (> 145 mmol/L).
  • - Participation in another interventional study at start of the study or during the study.
  • - Presence of known panic disorders or a history of panic attacks.

研究者

发起方
未提供

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