NCT01010802

Brief Summary

The purpose of this study is to determine whether recombinant human Erythropoietin (EPOrh) is safe in the treatment of patients with Parkinson's Disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1 parkinson-disease

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

1 active site

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

August 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 10, 2009

Completed
Last Updated

October 1, 2019

Status Verified

September 1, 2019

Enrollment Period

9 months

First QC Date

November 8, 2009

Last Update Submit

September 27, 2019

Conditions

Parkinson Disease

Keywords

NeuroprotectionParkinson DiseaseErythropoietin

Outcome Measures

Primary Outcomes (1)

  • safety assessment measured by the absence of adverse events

    weeks 1 to 5, 6, 12, 23 and 35

Secondary Outcomes (1)

  • Post-treatment change in the motor score of the Unified Assessment Scale for Parkinson Disease´s (UPDRS) in the "OFF" condition as compared with the baseline.

    week 6, 12, 23 and 35

Study Arms (1)

Erythropoietin

EXPERIMENTAL

There are evidences of neuroprotecting therapeutic alternatives in such substances as erythropoietin (EPO) which is a well-known cytokine as a hematopoietic growth factor, so, it is therefore important to control tissular oxygenation. It is considered that EPO protects the neurons by a combination of several mechanisms. EPOrh is used with high effectiveness in the treatment of anemias with deficiency of erythropoietin.

Drug: Erythropoietin human recombinant (EPOrh)

Interventions

Erythropoietin human recombinant (EPOrh)DRUG

Administration scheme by subcutaneous via, of an EPOrh solution up to a weekly doses of 60 UI/kg for five weeks

Also known as: EPOCIM® (Center of Molecular Immunology, Habana, Cuba)
Erythropoietin

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hohen and Yahr´s Scale between I and III
  • One or more years of evolution of PD,
  • Good response to levodopa (more that 30 % of change)valued in motor UPDRS
  • An acceptable general health status,

You may not qualify if:

  • Chronic psychiatric or other neurological diseases.
  • Previous polyglobulin
  • Hematocryte, same or inferior to 50

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic of Movement Disorders, International Center for Neurological Restoration

Havana, Cuba

Location

Related Publications (2)

  • Pedroso I, Bringas ML, Aguiar A, Morales L, Alvarez M, Valdes PA, Alvarez L. Use of Cuban recombinant human erythropoietin in Parkinson's disease treatment. MEDICC Rev. 2012 Jan;14(1):11-7. doi: 10.37757/MR2012V14.N1.4.

    PMID: 22334107RESULT

  • 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

MeSH Terms

Conditions

Parkinson Disease

Interventions

Erythropoietin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Ivonne Pedroso, M.D., M.Sc.

    International Center for Neurological Restoration

    PRINCIPAL INVESTIGATOR

  • Lazaro M Alvarez, M.D.

    International Center for Neurological Restoration

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Movement Disorders Clinic

Study Record Dates

First Submitted

November 8, 2009

First Posted

November 10, 2009

Study Start

August 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

October 1, 2019

Record last verified: 2019-09

Locations

CU(1)