Status:
COMPLETED
Study to Assess the Efficacy and Safety of MT-3921 in Subjects With Acute Traumatic Cervical Spinal Cord Injury
Lead Sponsor:
Tanabe Pharma America, Inc.
Conditions:
Spinal Cord Injury
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 elig...
Eligibility Criteria
Inclusion
- Additional screening criteria check may apply for qualification:
- Provide written informed consent prior to beginning any study procedures
- Cervical spinal cord injury that meet all of the following criteria:
- Classified as AIS A, AIS B or AIS C
- ISNCSCI neurological level of injury between C4 and C7 (for C4, the subject must have at least 1 point of motor activity between C5 to C7)
- UEMS ≤28 at Screening
- Body mass index (BMI) \<40
Exclusion
- Additional screening criteria check may apply for qualification:
- Any concomitant injury that interferes with the procedures and examinations required by study protocol, including performance, interpretation or validity of neurological examinations
- Poly-traumatic Injury as defined by Injury Severity Score (ISS) values \> 25
- Penetrating spinal cord injuries
- Complete transection of the spinal cord
- Any other significant pre-existing medical conditions prior to spinal cord injury or current conditions that, in the judgement of the iInvestigator, may increase the risks associated with study participation
- History of anaphylaxis or clinically significant allergic reactions to any medication
- History or presence of malignancy within the last 3 years prior to screening
- Subjects with current SARS-CoV-2 infection (COVID-19)
- Subjects with hereditary fructose intolerance
- Psychoactive substance use disorder
- Participation in any clinical trial of a new chemical entity within 12 weeks prior to Screening
- Female subjects who are pregnant or lactating
Key Trial Info
Start Date :
August 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2025
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04683848
Start Date
August 27 2021
End Date
April 9 2025
Last Update
December 16 2025
Active Locations (23)
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1
University of California Irvine
Orange, California, United States, 92868
2
Tallahassee Neurological Clinic
Tallahassee, Florida, United States, 32308
3
Augusta University
Augusta, Georgia, United States, 30912
4
University of Kentucky
Lexington, Kentucky, United States, 40536