A Phase 1/2 interventional study of NeuroEPO in Parkinson Disease, sponsored by International Center for Neurological Restoration, Cuba. Completed at 2 sites in Cuba. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-07-15.
Sponsored by International Center for Neurological Restoration, Cuba · Phase 1/2, Interventional, and Treatment
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.
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.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's enrollment of 26 is below the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →International Center for Neurological Restoration, Cuba is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The dose of NeuroEPO was a vial with a dose of 1 mL/1mg administered intra-nasally for five consecutive weeks.
Drug: NeuroEPO
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
NeuroEPO \[CIMAB S.A, Havana, Cuba\]
Also known as: Placebo
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.
Time frame: 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)
Time frame: 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
Time frame: day 1-5
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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International Center for Neurological Restoration, Cuba