Early acute spinal cord injury
Conditions
Brief summary
Incidence of treatment-emergent AEs and treatment-emergent SAEs between D1 and M6 in IMP plus SOC compared to SOC alone.
Detailed description
Absolute change in MAS and BPI from baseline to follow-up visits (M1, M3 and M6) in IMP plus SOC compared to SOC alone., Difference in length of stay observed in IMP plus SOC compared to SOC alone regarding: a. Time spent in the ICU [defined as time from ICU admission to discharge from ICU]. b. Time spent in the hospital [defined as time from hospital admission to discharge from hospital]., Absolute change in ASIA Impairment Scale (AIS) – ISNCSCI standards – motor and sensory scores from baseline to follow-up visits (M1, M3 and M6) in IMP plus SOC compared to SOC alone.
Interventions
DRUGRelert 40 mg comprimidos revestidos por película
Sponsors
Technophage Investigacao E Desenvolvimento Em Biotecnologia S.A.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent AEs and treatment-emergent SAEs between D1 and M6 in IMP plus SOC compared to SOC alone. | — |
Secondary
| Measure | Time frame |
|---|---|
| Absolute change in MAS and BPI from baseline to follow-up visits (M1, M3 and M6) in IMP plus SOC compared to SOC alone., Difference in length of stay observed in IMP plus SOC compared to SOC alone regarding: a. Time spent in the ICU [defined as time from ICU admission to discharge from ICU]. b. Time spent in the hospital [defined as time from hospital admission to discharge from hospital]., Absolute change in ASIA Impairment Scale (AIS) – ISNCSCI standards – motor and sensory scores from baseline to follow-up visits (M1, M3 and M6) in IMP plus SOC compared to SOC alone. | — |
Countries
Portugal, Spain
Outcome results
None listed