A Phase 3 interventional study of Erythropoietin and Methylprednisolone in Spinal Cord Injury, sponsored by Niguarda Hospital. Terminated at 1 site in Italy. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-03-14.
Sponsored by Niguarda Hospital · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the tolerability and efficacy of erythropoietin (EPO) treatment in spinal shock in comparison with the methylprednisolone treatment (MP).
Traumatic spinal cord injury (TSCI) is devastating for the patient and costly to society. Currently, methylprednisolone (MP) administered according NASCIS (III) protocol is the only therapy which has minor benefits and is accompanied by dangerous side effects. Any new treatment of TSCI that allows major recovery of function would be a significant advance in clinical care. Much of the motor and sensory paralysis following TSCI occurs because of a delayed and widespread oligodendrocyte apoptosis and demyelination of long spinal tracts. We have recently reported that erythropoietin (EPO) administration significantly attenuates such delayed secondary degeneration and promotes functional recovery in TSCI animal models. The research proposed is a multicenter trial involving the Italian Spinal Units that have developed a multidisciplinary experience on the management of TSCI. Primary objective of the study is to assess the superiority of EPO compared to MP in improving the clinical outcome of SCI (ASIA Impairment Scale); secondary objectives are: to assess the safety of EPO compared to MP, the effects on the motor and sensory functions and on improving functional autonomy, the influence on spasticity and neurogenic pain, and, the impact on surrogate end-points (Somatosensory Evoked Potentials and Magnetic Resonance Imaging).The study population is characterized by all patients with TSCI (ASIA Impairment Scale A or B) admitted to Italian Spinal Units: we estimate an enrolment of 100 subjects , 50 in each therapeutic arm. The study proposed is a single-blind randomized phase III parallel group trial in which eligible patients are randomized to one of the following treatment modalities: MP according to NASCIS III protocol or EPO iv (500 UI/kg within 8 hours after the SCI, dosage repeated at 24 and 48 hours). The duration of the study will be 24 months, with a 21-month maximum time to engage all the patients required by the power calculation.The primary end-point will be assessed using the Cochrane-Mantel-Haenzel test; the changes in the SEP (latency) and size of the MRI lesions using the Repeated Measures Analysis of Variance (ANOVA), the Ashworth, VAS, PENN, and SCIM scores with the parametric Wilcoxon's signed-ranks test. The effect of treatment on the primary end-point will be evaluated using a multivariate analysis model (binary logistic regression). The non-parametric alternative will be conducted if the assumption of normality will be not verified.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 10 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Niguarda Hospital is the lead sponsor of 66 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Methylprednisolone
Drug: Methylprednisolone
Erythropoietin
Drug: Erythropoietin
EPO 500 IU/kg diluted in 50 ml saline and infused in 30 minutes; treatment is started within eight hours after the spinal injury; the same drug dosage will be infused at 24 and 48 hours
MP 30 mg/kg intravenous (iv) in the first hour, followed by 5.4 mg/kg/h for 23 hours if treatment is started within three hours after the spinal injury,or for 48 hours if treatment is started between three and eight hours (protocol NASCIS III, National Acute Spinal Cord Injury Study)
Improvement of ASIA Impairment Scale of at least 1 grade. Score on ASIA Scale and a ASIA Impairment Scale are an inclusion criteria, then at 3rd, 7th, 14th, 30th, 60th, 90th days
Time frame: 3 months
Increase of ASIA motor/sensory scores at 3rd, 7th, 14th, 30th, 60th, 90th days
Time frame: 3 months
Functional autonomy with SCIM scores at 7th, 30th, 60th, 90th days
Time frame: 3 months
Spasticity with the Ashworth Scale, spasms with the PENN Scale and neurogenic pain with the VAS Scale at 7th, 14th days
Time frame: 3 months
This study is terminated, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Niguarda Hospital