- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04110678
Tolerance to NeuroEPO in Parkinson Disease (NeuroEPO)
Nasal Administration of the NeuroEPO in Parkinson Disease: Short-term Tolerance Physician Lead Trial
Study Overview
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
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Havana, Cuba
- Clinic of Movement Disorders, International Center for Neurological Restoration
-
La Habana, Cuba, 11300
- Centro Inmunologia Molecular CIM
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 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:
|
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
Collaborators
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
General Publications
- 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.
- Bringas Vega ML, Pedroso Ibáñez I, Razzaq FA, Zhang M, Morales Chacón 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.
- García-Llano M, Pedroso-Ibáñez I, Morales-Chacón L, Rodríguez-Obaya T, Pérez-Ruiz L, Sosa-Testé I, Amaro-González 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NeuroEPO-001-PD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedParkinson Disease 6, Early-Onset | Parkinson Disease (Autosomal Recessive, Early Onset) 7, Human | Parkinson Disease Autosomal Recessive, Early Onset | Parkinson Disease, Autosomal Recessive Early-Onset, Digenic, Pink1/Dj1United States
-
ProgenaBiomeRecruitingParkinson Disease | Parkinsons Disease With Dementia | Parkinson-Dementia Syndrome | Parkinson Disease 2 | Parkinson Disease 3 | Parkinson Disease 4United States
-
King's College LondonGlaxoSmithKlineCompletedParkinson Disease | Idiopathic Parkinson Disease | Parkinson Disease, PARK8United Kingdom
-
Ohio State UniversityCompletedParkinson's Disease | Parkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease | Parkinson Disease, Idiopathic | Parkinson's Disease, IdiopathicUnited States
-
National Yang Ming UniversityUnknownEarly Onset Parkinson Disease | Early Stage Parkinson Disease
-
Michele Tagliati, MDRecruitingREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Cedars-Sinai Medical CenterEnrolling by invitationREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Mahatma Gandhi Institute of Medical SciencesCompletedStroke, Parkinson' s Disease, Neurological Impairments, Tele-rehabilitationIndia
-
Merck Sharp & Dohme LLCCompletedParkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease
-
University of DeustoCompletedPARKINSON DISEASE (Disorder)Spain