euroEPO – Type 2 Spinocerebellar Ataxia Phase I-II
- Conditions
- Type 2 Spinocerebellar Ataxia
- Registration Number
- RPCEC00000187
- Lead Sponsor
- Center of Molecular Immunology (CIM), CIMAB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 34
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Spinocerebellar Ataxia Functional Index (SCAFI). Measuring time: Before and after NeuroEPO treatment (6 months).
- Secondary Outcome Measures
Name Time Method