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NCT04683848 · ClinicalTrials.gov registry record · Phase 2
Study to Assess the Efficacy and Safety of MT-3921 in Subjects With Acute Traumatic Cervical Spinal Cord Injury
A Phase 2 study of Spinal Cord Injury, sponsored by Tanabe Pharma America.
- Completed
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
- 20
- Study locations
NCT04683848: Completed Phase 2 study of Spinal Cord Injury, sponsored by Tanabe Pharma America.
NCT04683848 is a Phase 2 study of Spinal Cord Injury that has completed, run by Tanabe Pharma America. The registered enrollment target is 72 participants, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (16% lower). The trial reports 20 study locations across 19 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04683848, a Phase 2 study of Spinal Cord Injury, has completed, sponsored by Tanabe Pharma America.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The UEMS is a subscore of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) that focuses selectively on function of 5 key muscles in the upper limbs. UEMS ranges from 0 to 50 points, where a higher score indicates a better movement.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL MT-3921
Study Locations (20)
Texas
- Brooke Army Medical Center in San Antonio - Houston
- The University of Texas Health Science Center at San Antonio - San Antonio
California
- University of California Irvine - Orange
Florida
- Tallahassee Neurological Clinic - Tallahassee
Georgia
- Augusta University - Augusta
Kentucky
- University of Kentucky - Lexington
Michigan
- Spectrum Health - Grand Rapids
Mississippi
- University of Mississippi Medical Center - Jackson
Missouri
- Saint Louis University Hospital - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2021-08-27 |
| Est. Completion | 2025-04-09 |
| Phase | Phase 2 |
What the finished NCT04683848 record still lists
NCT04683848 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (16% lower).
The record links to 1 condition, with Spinal Cord Injury appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04683848 names 20 study sites across 19 states, led by Texas, California, Florida.
Frequently Asked Questions
What is clinical trial NCT04683848 about?
NCT04683848 is a clinical study titled "Study to Assess the Efficacy and Safety of MT-3921 in Subjects With Acute Traumatic Cervical Spinal Cord Injury". 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 ra...
What is the current status of trial NCT04683848?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2021-08-27. Estimated completion is 2025-04-09.
What conditions does trial NCT04683848 study?
This clinical trial studies the following conditions: Spinal Cord Injury.
What interventions are being tested in trial NCT04683848?
The interventions under investigation include: Placebo (BIOLOGICAL), MT-3921 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04683848?
This trial is sponsored by Tanabe Pharma America, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04683848 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Kentucky, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Spinal Cord Injury
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04683848's enrollment target sits among peer trials
72 28th of 99 higher than 72 of 99 other Spinal Cord Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Spinal Cord Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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