NCT04683848

Study to Assess the Efficacy and Safety of MT-3921 in Subjects With Acute Traumatic Cervical Spinal Cord Injury

A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of MT-3921 in Subjects With Acute Traumatic Cervical Spinal Cord Injury

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Tanabe Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy and safety of intravenous (IV) infusions of MT-3921 to placebo in subjects with acute traumatic cervical spinal cord injury. Subjects meeting eligibility criteria will enter the 6-month double-blind period. Subjects will be randomized in a 2:1 ratio to receive MT-3921 or placebo in a double blind manner.

Conditions

• Spinal Cord Injury

Interventions

Type	Name	Description
BIOLOGICAL	MT-3921	Solution for infusion; Intravenous (IV)
BIOLOGICAL	Placebo	Solution for infusion; Intravenous (IV)

Timeline

• Start date: 2021-08-27
• Primary completion: 2024-12-24
• Completion: 2025-04-09
• First posted: 2020-12-24
• Last updated: 2025-12-16

Locations

23 sites across 3 countries: United States, Canada, Japan

Regulatory

• FDA-regulated drug study