NeuroEPO in patients with Parkinson disease stage II-III

• Register: RPCEC
• Last refreshed on: 29 April 2024
• Main ID: RPCEC00000233
• Date of registration: 01/02/2017
• Prospective Registration: Yes
• Primary sponsor: Center of Molecular Immunology (CIM)
• Public title: NeuroEPO in patients with Parkinson disease stage II-III
• Scientific title: Assessing the efficacy and safety of nasal NeuroEpo management in Patients disease with Parkinson stage II-III - mAkEUP
• Date of first enrolment: 08/12/2017
• Target sample size: 102
• Recruitment status: Complete
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000233-En
• Study type: Interventional
• Study design: Allocation: Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment
• Phase: 2-3

Countries of recruitment

Cuba

Contacts

• Name: Ivonne Pedroso Ibannez
• Affiliation: International Center of Neurologic Restoration (CIREN)

• Name: Leslie Perez Ruiz
• Affiliation: Center of Molecular Immunology (CIM)

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patients with Parkinson's disease, who meet the diagnostic criteria of BBL and stage II-III according to Hoehn and Yahr scale.
2. Patients older than 18 years.
3. One or more years of evolution of motor symptoms.
4. Good response to dopaminergic stimulation.
5. Acceptable general health status, not previous polygllobulia (Hto equal or lower than 50).
6. Patients who consent to participate in the study by signing the informed consent model.

Exclusion criteria: 1. Negative patient to participate in the study.
2. Presence of signs indicative of cognitive deterioration or psychiatric complications at the time of study.
3. Presence of accidents or other diseases during the therapeutic period that disqualify the patient to clinical trial.
4. Patients with known hypersensitivity to any component of the formulation.
5. Patients who are pregnant or breastfeeding.
6. Patients of childbearing potential not using contraceptive methods.
7. Patients with uncontrolled hypertension (systolic pressure mayor 180 mmHg and / or diastolic pressure mayor 120 mmHg).
8. Patients receiving treatment with immunosuppressants, androgens or anabolic steroids in the month prior to inclusion.
9. Patients with haematological diseases: sickle cell, myelodysplastic syndromes, coagulation disorders or active bleeding.
10. Patients with severe hyperparathyroidism.
11. Patients diagnosed with malignant tumor or anticancer therapy.
12. Patients with decompensated psychiatric illness.
13. Patients with alcoholism or drug addiction in the two years prior to the evaluation for inclusion.


Age minimum: 18 years
Age maximum: None
Gender: Male/Female

Health Condition(s) or Problem(s) studied

Parkinson Diseases

Parkinsonian Disorders

Brain Diseases

Movement Disorders

Nervous System Diseases

Central Nervous System Diseases

Basal Ganglia Diseases

Parkinson's disease stage II-III

Neurodegenerative Diseases

Intervention(s)

Administration, Intranasal

Erythropoietin

Placebos

Neuroprotective Agents

NeuroEPO

Group A (experimental): 0.5 mg NeuroEPO by intranasal route, 3 times a week for 4 weeks (induction period) and, then continue with 1mg weekly for 20 weeks (maintenance period).
Group B (experimental): 1.0 mg NeuroEPO by intranasal route, 3 times a week for 4 weeks (induction period) and then, continue with the same doses weekly for 20 weeks (maintenance period).
Group C (control): Placebo. This group will be divide in two equal subgroups (one for each experimental group). The patients will receive the same doses, schema and administration route.

Primary Outcome(s)

Total UPDRS Value (UPDRS scale). Measuring time: 9 months.

Secondary Outcome(s)

Related to eficacy
1. UPDRS motor. measure by UPDRS III. Measuring time: 0, 6, 9 months
2. Daytime mobility fluctuations: measured by self-report. Measure by: Presence of on/off (on and off) dyskinesias (yes/no), dystonias (score), paradoxical fluctuations (score). Measuring time: 0, 6, 9 months
3. Total dose of dopaminergic stimulation. Measure by percentage. Measuring time: in each administration of the product.
4. Cognitive impairment. Measured by the DRS (Dementia Rating Scale) by Mattis. Measuring time:: 0, 9 months
5. Mental flexibility. Measured by the Trail Test (TMT). Measuring time: 0, 9 months
6. Working Memory. Measured by the TMT. Measuring time: 0, 9 months
7. Motor response rate. Measured by the TMT. Measuring time: 0, 9 months
8. Sustained attention. Measured by subtest 2 of the WAIS III Working Memory Index. Measuring time: 0, 9 months
9. Working memory. Measured by subtest 2 of the WAIS III Working Memory Index. Measuring time: 0, 9 months
10. Phonological verbal fluency. Measured by the Verbal Fluency Test (FAST). Measuring time: 0, 9 months
11. Semantic verbal fluency. Measured by FAST. Measuring time: 0, 9 months
12. Ability to alternate mental categories. Measured by FAST. Measuring time: 0, 9 months
13. Executive function. Measured by Litvan Frontal Assessment Battery (FAB). Measuring time: 0, 9 months
14. Selective attention (Measured by Stroop test). Measuring time:: 0, 9 months
15. Focused attention (Measured by Stroop test). Measuring time: 0, 9 months
16. Visuoconstructive function (Measured by Fig. De Rey). Measuring time: 0, 9 months
17. Visual memory (Measured by Fig. Of Rey). Measuring time:: 0, 9 months
18. Level of anxiety. Measured by the HADS (Hospital Anxiety and Depression Scale) Hospital Anxiety and Depression Scale. Measuring time: 0, 9 months
19. Level of depression. Measured by HADS. Measuring time: 0, 9 months
Related to safety:
20. Adverse Events-AE (Severity of AE (serious or not), Type of AE (accordint to Regulation 45/2007 CECMED), Intensity of AE (mild, moderate, serious), Causality relationship (Very likely, Likely, possible, unlikely, unrelated or non-evaluable), Attitude about the drug (No change, dose reduction, temporary interruption of treatment, definitive discontinuation of treatment), Outcome (Reversible effect, irreversible effect, death, loss of patient follow-up)). Measuring time: in each evaluation at 6 and 9 months and in each administration of the product.
21. Laboratory test (Hemoglobin (Normal, abnormal), Hematocrit (Normal, abnormal), Platelet count (Normal, abnormal), Leukocyte count (Normal, abnormal), Glycemia (Normal, abnormal), TGO (Normal, abnormal), TGP (Normal, abnormal), GGT (Normal, abnormal), Creatinine, (Normal, abnormal), uric acid (Normal, abnormal), urea (normal, abnormal)). Measuring time: 0, 6 and 9 months.
22. Blood pressure (mm/Hg). Measuring time: in each evaluation at 0, 6 and 9 months and in each administration of the product.

Secondary ID(s)

Not applicable

Source(s) of Monetary Support

Center of Molecular Immunology (CIM)Ministry of Public Health (MINSAP)

Secondary Sponsor(s)

Not applicable

Results

• Results available: Yes
• Date Posted: 31/07/2023
• Date Completed: 31/07/2023