CTIS2022-503016-16-00进行中（未招募）1 期
A double-blind, randomized, placebo-controlled trial to test the efficacy, safety and tolerability of Dimethyl Fumarate in Friedreich Ataxia (DMF-FA-201). - DMF-FA-201
Dipartimento Di Neuroscienze E Scienze Riproduttive Ed Odontostomatologiche Universita Degli Studi Di Napoli Federico II0 个研究点目标入组 40 人开始时间: 2022年12月29日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 65+（—）
- 性别
- All
入选标准
- •Molecular diagnosis of Friedreich Ataxia with a homozygous GAA expansion, Age =12 years, Body weight =30 Kg, Patients able to read and sign the informed consent
排除标准
- •Treatment with DMF in the previous 12 months, Positive history of alcohol or drug abuse in the past 2 years, except for medical use of cannabis, Hypersensitivity to DMF or any other component of the study drug, Patients not able to comply with the study, For female patients (Sexually not active, hysterectomized, sterilized, menopause patients are excluded from the following criteria): - Pregnancy, or - Breastfeeding, or - Inadequate contraception, Treatment with Idebenone, coenzyme Q10, or any other vitamin supplements in the previous 30 days, Patients in treatment with any other not allowed drug, Any Cardiac and/or Renal and/or Hepatic disease judged as clinically significant by the investigator (any abnormal and clinically non significant cardiac disease associated with Friedreich Ataxia is not an exclusion criteria), Any clinically significant ECG abnormalities that may interfere with the study, Any abnormal and clinically significant laboratory exams at screening visit that may interfere with the trial, Any acute disease that could interfere with the study, as judged by the investigator, Patient positive to the Human Immunodeficiency Virus (HIV) or Hepatitis B or C test, Patients with a positive history of neoplasia, with the only exception of a completely excided basal cell carcinoma
研究者
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