A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Assess the Safety and Efficacy of Elezanumab in Acute Traumatic Cervical Spinal Cord Injury

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505125-14-00

Acronym

M16-077

Enrollment

Registered

2023-11-08

Start date

2020-07-24

Completion date

2026-01-21

Last updated

2023-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Traumatic Cervical Spinal Cord Injury

Brief summary

The primary endpoint is the Upper Extremity Motor Score (UEMS), a subscore of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI, 2019 criteria) during the Treatment Period.

Detailed description

Spinal Cord Independence Measures (SCIM III) self-care score, UEMS change from baseline

Interventions

DRUGElezanumab

DRUGPlacebo Solution for Injection or Infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the Upper Extremity Motor Score (UEMS), a subscore of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI, 2019 criteria) during the Treatment Period.	—

Secondary

Measure	Time frame
Spinal Cord Independence Measures (SCIM III) self-care score, UEMS change from baseline	—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026