Status:
COMPLETED
Tolerance to NeuroEPO in Parkinson Disease
Lead Sponsor:
International Center for Neurological Restoration, Cuba
Collaborating Sponsors:
Center of Molecular Immunology, Cuba
University of Electronic Science and Technology of China
Conditions:
Parkinson Disease
Eligibility:
All Genders
40-70 years
Phase:
PHASE1
PHASE2
Brief Summary
Treatment strategies in Parkinson's disease (PD) can improve a patient's quality of life but cannot stop the progression of PD. The investigators are looking for different alternatives that modify the...
Detailed Description
Delivery of therapeutic agents as erythropoietin (EPO) into Central Nervous System through intranasal route could benefit patients with neurological disorders. A new nasal formulation containing a non...
Eligibility Criteria
Inclusion
- Patient who fulfilled the London Brain Bank's operational criteria for PD
- Willing to participate in the study;
- ≥1 year since disease onset;
- Good response to antiparkinsonian treatment with levodopa (\>30% change in motor score on the motor section of the Unified Parkinson's Disease
- no prior poly globulin (hematocrit ≤50%);
Exclusion
- Refusal to participate;
- Known hypersensitivity to products derived from eukaryotes or hypersensitivity to human albumin;
- Pregnancy or breastfeeding;
- Hypertension;
- Immunosuppressant, androgen or anabolic steroid treatment in the month prior to recruitment;
- Sepsis or active infection;
- Active acute or chronic inflammatory diseases;
- Haematological diseases, such as sickle cell disease, myelodysplastic syndromes, active clotting or bleeding disorders;
- Malignant tumor or cancer treatment;
- Alcoholism or drug addiction in the two years prior to inclusion assessment.
- Significant cognitive decline as measured by clinical assessment, DRS (Dementia Rating Scale) and the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV).
Key Trial Info
Start Date :
November 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04110678
Start Date
November 1 2015
End Date
January 1 2017
Last Update
July 15 2020
Active Locations (2)
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1
Clinic of Movement Disorders, International Center for Neurological Restoration
Havana, Cuba
2
Centro Inmunologia Molecular CIM
La Habana, Cuba, 11300