A double-blind, randomized, placebo-controlled, clinical trial to test the efficacy of Epoetin alfa on physical performance of Friedreich Ataxia patients. - FRIEMAX

IVERSITA' DEGLI STUDI DI NAPOLI FEDERICO II0 个研究点开始时间: 2012年7月26日最近更新: 2017年7月17日

适应症

试验速览

暂无简介。

•Molecular diagnosis of Friedreich Ataxia • Age =12 years • Body weight =30 Kg • SARA score =30 • Patient able to read and sign the informed consent
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 10
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 50
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Treatment with Erythropoietin in the previous 12 months • Treatment with Idebenone • Contraindications to cardiopulmonary test: valvulopathies, ischemic cardiomyopathy, atrial fibrillation, asthma, chronic obstructive pulmonary disease, other arrhythmias judged as not compatible with exercise. • Any Cardiac and/or Hepatic and/or Renal 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 • Anemia with Hemoglobin <10 g/dL • Positive history for venous and/or arterial thrombosis • Drug-resistant arterial hypertension • Positive history for drug-resistant epilepsy • Patients in treatment with not allowed study drugs (starting from 1 month prior to screening) • Any acute/chronic disease that might interfere with the clinical trial, as judged by the investigator • Hypersensitivity to Epoetin alfa or any other component of the study drug • Patients not able to comply to the study • For female patients (Sexually not active, hysterectomized, sterilized, menopause patients are excluded from the following criteria): - Pregnancy, or - Breastfeeding, or - Inadequate contraception

发起方

IVERSITA' DEGLI STUDI DI NAPOLI FEDERICO II