Tolerance to NeuroEPO in Parkinson Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT04110678
• Date of registration: 18/09/2019
• Prospective Registration: No
• Primary sponsor: International Center for Neurological Restoration, Cuba
• Public title: Tolerance to NeuroEPO in Parkinson Disease NeuroEPO
• Scientific title: Nasal Administration of the NeuroEPO in Parkinson Disease: Short-term Tolerance Physician Lead Trial
• Date of first enrolment: November 1, 2015
• Target sample size: 26
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT04110678
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 1/Phase 2

Countries of recruitment

Cuba

Contacts

• Name: Daniel E Amaro Gonzalez, PhD Eng
• Affiliation: Centro Inmunologia Molecular CIM Havana Cuba

• Name: Teresita Rodríguez Obaya, PhD
• Affiliation: Centro Immunologia Molecular CIM Havana Cuba

• Name: Iliana Sosa Teste, PhD
• Affiliation: Centro Nacional Producción Animales de Laboratorio (CENPALAB) Cuba

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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).



Age minimum: 40 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: NeuroEPO

Primary Outcome(s)

Number of participants with local nasal events [Time Frame: day 1-5]

Number or participants with increment in the haematological and biochemistry parameters [Time Frame: day 0 day 5 and day 14]

Change from Baseline Systolic Blood Pressure after each intervention [Time Frame: day 1-5]

Secondary ID(s)

NeuroEPO-001-PD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Center of Molecular Immunology, Cuba

University of Electronic Science and Technology of China