Phase III clinical trial, placebo-controlled, randomized and double-blind to assess the efficacy and safety of NeuroEPO nasal administration in adult patients with spinocerebellar ataxias. - NESCA

Center of Molecular Immunology (CIM)0 个研究点目标入组 80 人开始时间: 2020年11月19日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment

•1. Suffering from decompensated chronic diseases (Cardiopathies, Diabetes Mellitus, Arterial Hypertension, Chronic Renal Failure, Bronchial Asthma, etc.).
•2. Parkinson's manifestations and/or frontotemporal dementia.
•3. History of any other degenerative or systemic neurological disease with an impact on the nervous system.
•4. History of psychiatric illnesses.
•5. Known bleeding disorders or active bleeding.
•6. Patient who is being treated with anti-aguerants or anticoagulants.
•7. Severe acute diseases at the time of inclusion.
•8. Pregnant or lactating woman.
•9. Patient with reproductive and sexually active capacity who does not agree to use at least one effective method of contraception prior to inclusion in the study and/or during participation in the clinical trial (in the case of the female sex: intrauterine devices, barrier methods, hormones or tubal ligation and in the case of the male sex: vasectomy, condom use).
•10. Hypersensitivity to the active substance (recombinant human erythropoietin) or to any of the active substances that make up the product.
•11. You are participating in another clinical trial.
•12. History of alcoholism and/or pharmacodependence.

发起方

Center of Molecular Immunology (CIM)