NCT04110678

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 natural course of the disease and recent research has demonstrated the neuroprotective properties of erythropoietin. In Cuba, the Center for Molecular Immunology (CIM) is a cutting edge scientific center where the recombinant form (EPOrh) and recombinant human erythropoietin with low sialic acid (NeuroEPO) are produced.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P50-P75 for phase_1 parkinson-disease

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 1, 2019

Completed
Last Updated

July 15, 2020

Status Verified

July 1, 2020

Enrollment Period

3 months

First QC Date

September 18, 2019

Last Update Submit

July 13, 2020

Conditions

Parkinson Disease

Keywords

Parkinson DiseaseToleranceNeuroEPOside effectsUPDRSCognition

Outcome Measures

Primary Outcomes (3)

  • Number of participants with local nasal events

    the administration of the drug is intra-nasal for that reason the first adverse event to study is the irritation of the nose. The presence of toxicity signs in the nasal mucous, such as: redness, swelling and nasal congestion was evaluated by means of thorough medical examination of the nasal cavity by the same Otorhinolaryngology Specialist.

    day 1-5

  • Number or participants with increment in the haematological and biochemistry parameters

    the blood tests were obtained to evaluate hematological counts (reticulocytes, hemoglobin, hematocrit, leukocytes), coagulation parameters (platelet count, partial thromboplastin and prothrombin times) and blood chemistry (glycemia, creatinine, urea, liver enzymes)

    day 0 day 5 and day 14

  • Change from Baseline Systolic Blood Pressure after each intervention

    The vital signs and the physical checkup was permanent before and after each application. The change of the baseline systolic blood pressure could be a criteria for suspension of the treatment

    day 1-5

Study Arms (2)

NeuroEPO

ACTIVE COMPARATOR

The dose of NeuroEPO was a vial with a dose of 1 mL/1mg administered intra-nasally for five consecutive weeks.

Drug: NeuroEPO

Placebo

PLACEBO COMPARATOR

The dose of placebo was a vial with a dose of 1 mL/1mg of an intranasal inert solution administered intra-nasally for five consecutive weeks.

Drug: NeuroEPO

Interventions

NeuroEPODRUG

NeuroEPO \[CIMAB S.A, Havana, Cuba\]

Also known as: Placebo
NeuroEPOPlacebo

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%);

You may not qualify if:

  • 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;
  • Significant cognitive decline as measured by clinical assessment, DRS (Dementia Rating Scale) and the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinic of Movement Disorders, International Center for Neurological Restoration

Havana, Cuba

Location

Centro Inmunologia Molecular CIM

La Habana, 11300, Cuba

Location

Related Publications (3)

  • Pedroso I, Garcia M, Casabona E, Morales L, Bringas ML, Perez L, Rodriguez T, Sosa I, Ricardo Y, Padron A, Amaro D. Protective Activity of Erythropoyetine in the Cognition of Patients with Parkinson's Disease. Behav Sci (Basel). 2018 May 21;8(5):51. doi: 10.3390/bs8050051. eCollection 2018 May.

    PMID: 29862060RESULT

  • Bringas Vega ML, Pedroso Ibanez I, Razzaq FA, Zhang M, Morales Chacon L, Ren P, Galan Garcia L, Gan P, Virues Alba T, Lopez Naranjo C, Jahanshahi M, Bosch-Bayard J, Valdes-Sosa PA. The Effect of Neuroepo on Cognition in Parkinson's Disease Patients Is Mediated by Electroencephalogram Source Activity. Front Neurosci. 2022 Jun 30;16:841428. doi: 10.3389/fnins.2022.841428. eCollection 2022.

    PMID: 35844232DERIVED

  • Garcia-Llano M, Pedroso-Ibanez I, Morales-Chacon L, Rodriguez-Obaya T, Perez-Ruiz L, Sosa-Teste I, Amaro-Gonzalez D, Bringas-Vega ML. Short-term Tolerance of Nasally-administered NeuroEPO in Patients with Parkinson Disease. MEDICC Rev. 2021 Jan;23(1):49-54. doi: 10.37757/MR2021.V23.N1.10. Epub 2021 Jan 30.

    PMID: 33780423DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Daniel E Amaro Gonzalez, PhD Eng

    Centro Inmunologia Molecular CIM Havana Cuba

    PRINCIPAL INVESTIGATOR

  • Teresita Rodríguez Obaya, PhD

    Centro Immunologia Molecular CIM Havana Cuba

    STUDY CHAIR

  • Iliana Sosa Teste, PhD

    Centro Nacional Producción Animales de Laboratorio (CENPALAB) Cuba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Randomization will be performed by the promoter institution Centro Inmunologia Molecular from Spanish CIM who assigned the selected patients to two groups neuroEPO and placebo giving a code. The specialists at CIREN didn't have access to the information. Both groups received a vial of the molecule with identical organoleptic characteristics.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, blinded, Physician lead trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Movement Disorders Clinic

Study Record Dates

First Submitted

September 18, 2019

First Posted

October 1, 2019

Study Start

November 1, 2015

Primary Completion

February 11, 2016

Study Completion

January 1, 2017

Last Updated

July 15, 2020

Record last verified: 2020-07

Locations

CU(2)