Build status - In Progress

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

Recruiting
99 years or below
All
Phase 2
10 participants needed
1 Location

Brief description of study

The objectives of the study are to assess the safety and efficacy of elezanumab in subjects with acute traumatic cervical SCI. 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. The primary analysis will be the comparison of a model-based area under the curve (AUC) of the UEMS scores between treatment and placebo. The secondary endpoints are the Spinal Cord Independence Measures (SCIM III) self-care score, and the change in UEMS from Baseline.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Medical Research
  • Age: 99 years or below
  • Gender: All
Updated on 09 Feb 2022. Study ID: 844979

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