Parkinson DiseasePhase 1NCT01010802
Safety Study of Erythropoietin (EPO) in Parkinson's Disease
A Phase 1 study testing Erythropoietin human recombinant (EPOrh) in people with Parkinson Disease, run by International Center for Neurological Restoration, Cuba at 1 site in Cuba.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Erythropoietin human recombinant (EPOrh)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCuba
- Study dates
- Aug 2008to May 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- Chronic psychiatric or other neurological diseases.
- Previous polyglobulin
- Hematocryte, same or inferior to 50
Trial locations and contacts
1 site in 1 country.
Cuba1 site
Clinic of Movement Disorders, International Center for Neurological Restoration
Havana
About this study
Official title: Phase 1 Study of Recombinant Human Erythropoietin (rhEPO) in Parkinson's Disease (PD)
The purpose of this study is to determine whether recombinant human Erythropoietin (EPOrh) is safe in the treatment of patients with Parkinson's Disease.
Read the detailed description
After onset of Parkinson's Disease (PD)- in spite of the use of medications that constitute the symptomatic treatment- the disease is worsens with an inevitable progression, thus causing complications that lead to the loss of patient´s manual skills and independent gait. At present, the treatment of PD with the use of medications is based on dopamine precursors and dopaminergic agonists but as the disease advances, other symptoms that do not respond to dopaminergic stimulation do appear.
For this reason, it is a priority to find a way to focus on neuroprotection during the course of the disease. There are evidences of neuroprotecting therapeutic alternatives in such substances as erythropoietin (EPO).
Positive results on the neuroprotective/neurotrophic efficacy of EPO in neurological and psychiatric diseases have been obtained from treatment trials, but nevertheless, it is indispensable demonstrate that with the proposed medication doses it's well tolerated by PD patients.
- Conditions
- Parkinson Disease
- Being tested
- Erythropoietin human recombinant (EPOrh)
- Keywords
- Neuroprotection, Parkinson Disease, Erythropoietin
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erythropoietin human recombinant (EPOrh)Drug
Also called EPOCIM® (Center of Molecular Immunology, Habana, Cuba)
Administration scheme by subcutaneous via, of an EPOrh solution up to a weekly doses of 60 UI/kg for five weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Erythropoietin human recombinant (EPOrh) |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety assessment measured by the absence of adverse events
Measured: 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.
Measured: week 6, 12, 23 and 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2009 (estimated)
- Study startAug 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Center for Neurological Restoration, Cuba
- Sponsor type
- University, hospital or other
- Collaborators
- Centro de Immunologia Molecular, Cuba
- Responsible party
- Principal investigator, Ivonne Pedroso Ibanez, International Center for Neurological Restoration, Cuba
- Investigators
- Ivonne Pedroso, M.D., M.Sc., Principal investigator, International Center for Neurological RestorationLazaro M Alvarez, M.D., Study director, International Center for Neurological Restoration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010802
- Sponsor's protocol ID
- EPO-001-PD
- Status last verified
- Sep 2019
- First submitted
- 8 Nov 2009
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22334107Pedroso 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.
PubMed 29862060
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Recombinant Human Erythropoietin (rhEPO) in Parkinson's Disease (PD)
- ClinicalTrials.gov ID
- NCT01010802
- Acronym / sponsor ID
- EPO-001-PD
- Conditions
- Parkinson Disease
- Keywords
- Neuroprotection, Parkinson Disease, Erythropoietin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- International Center for Neurological Restoration, CubaUniversity, hospital or other
- Collaborators
- Centro de Immunologia Molecular, Cuba
- Study start
- Aug 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 10 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether recombinant human Erythropoietin (EPOrh) is safe in the treatment of patients with Parkinson's Disease.
Detailed description
After onset of Parkinson's Disease (PD)- in spite of the use of medications that constitute the symptomatic treatment- the disease is worsens with an inevitable progression, thus causing complications that lead to the loss of patient´s manual skills and independent gait. At present, the treatment of PD with the use of medications is based on dopamine precursors and dopaminergic agonists but as the disease advances, other symptoms that do not respond to dopaminergic stimulation do appear.
For this reason, it is a priority to find a way to focus on neuroprotection during the course of the disease. There are evidences of neuroprotecting therapeutic alternatives in such substances as erythropoietin (EPO).
Positive results on the neuroprotective/neurotrophic efficacy of EPO in neurological and psychiatric diseases have been obtained from treatment trials, but nevertheless, it is indispensable demonstrate that with the proposed medication doses it's well tolerated by PD patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erythropoietin | Experimental | Drug: Erythropoietin human recombinant (EPOrh)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. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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,
Key exclusion criteria (3 listed)
- Chronic psychiatric or other neurological diseases.
- Previous polyglobulin
- Hematocryte, same or inferior to 50
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erythropoietin human recombinant (EPOrh)Also: EPOCIM® (Center of Molecular Immunology, Habana, Cuba)Administration scheme by subcutaneous via, of an EPOrh solution up to a weekly doses of 60 UI/kg for five weeks | Drug | Erythropoietin |
Primary outcome
safety assessment measured by the absence of adverse events
Time frame: weeks 1 to 5, 6, 12, 23 and 35
1 secondary outcome
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.
Time frame: week 6, 12, 23 and 35
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Results publication: PubMed 22334107Pedroso 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.
- Results publication: PubMed 29862060Pedroso 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivonne Pedroso, M.D., M.Sc. principal investigator
International Center for Neurological Restoration
Lazaro M Alvarez, M.D. study director
International Center for Neurological Restoration
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Erythropoietin human recombinant (EPOrh) in people with Parkinson Disease, run by International Center for Neurological Restoration, Cuba at 1 site in Cuba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cuba. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety assessment measured by the absence of adverse events (time frame: weeks 1 to 5, 6, 12, 23 and 35). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01010802, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.