Evaluation of the safety and effect of treatment with intranasal NeuroEPO in patients with type 2 Spinocerebellar Ataxia” - NeuroEPO-Ataxia

Center of Molecular Immunology (CIM), CIMAB0 个研究点目标入组 34 人开始时间: 2014年11月2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.Patients with clinical and molecular diagnosis of stage I-II Type 2 Spinocerebellar Ataxia.
•2.Patients of both gender, with age between 18 and 80 years (both included).
•3.Written informed consent given by the patient.
•4.Vital signs within normal limits.
•Systolic blood pressure until 140 mm Hg
•Diastolic blood pressure until 90 mm Hg
•Heart rate 60-100 x minute
•Respiratory rate 16-20 x minute

•1.Antecedents of alcoholism and drug dependency.
•2.Antecedents of any other degenerative or systemic neurological disease with repercussion on the nervous system.
•3.Antecedents of psychiatric diseases.
•4.Hematological diseases such as thrombocytosis, anticoagulation, antecedents of thrombotic events.
•5.Severe acute diseases at entry.
•6.Decompensate chronic diseases associated to SCA2.
•7.Chronic inflammatory diseases, Epilepsy, diabetes mellitus, cardiac insufficiency.
•8.Patient with folic iron and vitamin B12 supplementation.
•9.Pregnancy or nursing.
•10.Patients with dementia symptoms.
•11.Had been operated in the previous six months,
•12.Patients with hypersensibility to human recombinant erythropoietin or some ingredient of the formulation.
•13.Rhinitis
•14.Patients with deviated nasal septum.
•15.Parallel participation in another clinical trial.

发起方

Center of Molecular Immunology (CIM), CIMAB