Tolerance to NeuroEPO in Parkinson Disease (NeuroEPO)

July 13, 2020 updated by: Ivonne Pedroso Ibanez, International Center for Neurological Restoration, Cuba

Nasal Administration of the NeuroEPO in Parkinson Disease: Short-term Tolerance Physician Lead Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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-hematopoietic recombinant EPO (NeuroEPO) has shown neuroprotective actions in preclinical models and the safety trial of NeuroEPO was evaluated for the first time in humans in Cuba.

The researchers previously conducted a proof of concept clinical trial, administering EPOrh subcutaneously where the neuropsychological performance was measured as a secondary endpoint. This protocol has the register number NCT01010802. Results showed an increased neuropsychological performance of patients after administration as compared to before administration results.

In this protocol two institutions were leading a physician clinical trial.The two institutions: International Center for Neurological Restoration (CIREN from Centro Internacional de Restauracion Neurologica from Spanish) where the recruitment and clinical evaluation of the PD patients will be done and the Center for Molecular Immunology, who was the promoter.

Randomisation will be performed by the CIM to assign the patients to groups. The groups will receive neuroEPO or placebo with identical organoleptic characteristics. The informed consent of all patients will be obtained before the start of the trial after the selection and primary evaluation of the inclusion criteria.

The dose of neuroEPO will be a vial with a dose of 1 mL/1mg administered intra-nasally for five consecutive weeks. The placebo group was administered 1 mL of an intranasal inert solution for the same period of time.

The IBM SPSS Statistics V 21 package will be used for the statistical analysis of the data. The investigators will use tables of frequency analysis and descriptive statistics to analyse the demographic characteristics of the sample.

The analysis of the results obtained will be done studying the differences between quantitative variables for paired and unpaired samples, the Wilcoxon and U of Mann-Whitney tests will be used respectively. For the qualitative variables Chi square (X2) test will be used. All values of p < 0.05 will be considered significant.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Havana, Cuba
        • Clinic of Movement Disorders, International Center for Neurological Restoration
      • La Habana, Cuba, 11300
        • Centro Inmunologia Molecular CIM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: NeuroEPO
The dose of NeuroEPO was a vial with a dose of 1 mL/1mg administered intra-nasally for five consecutive weeks.
NeuroEPO [CIMAB S.A, Havana, Cuba]
Other Names:
  • Placebo
Placebo Comparator: Placebo
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.
NeuroEPO [CIMAB S.A, Havana, Cuba]
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with local nasal events
Time Frame: day 1-5
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
Time Frame: day 0 day 5 and day 14
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
Time Frame: day 1-5
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Daniel E Amaro Gonzalez, PhD Eng, Centro Inmunologia Molecular CIM Havana Cuba
  • Study Chair: Teresita Rodríguez Obaya, PhD, Centro Immunologia Molecular CIM Havana Cuba
  • Principal Investigator: Iliana Sosa Teste, PhD, Centro Nacional Producción Animales de Laboratorio (CENPALAB) Cuba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

February 11, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

September 18, 2019

First Submitted That Met QC Criteria

September 27, 2019

First Posted (Actual)

October 1, 2019

Study Record Updates

Last Update Posted (Actual)

July 15, 2020

Last Update Submitted That Met QC Criteria

July 13, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson Disease

3
Subscribe