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Clinical Trials/RPCEC00000187
RPCEC00000187
Not Yet Recruiting
Phase 1

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 sites34 target enrollmentNovember 2, 2014
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ConditionsType 2 Spinocerebellar Ataxia

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Type 2 Spinocerebellar Ataxia
Sponsor
Center of Molecular Immunology (CIM), CIMAB
Enrollment
34
Status
Not Yet Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 2, 2014
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Center of Molecular Immunology (CIM), CIMAB

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

Not specified

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