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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2031210320 | Registry Identifier | Japan Registry of Clinical Trials (jRCT) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT-3921 | Experimental | Intravenous (IV) |
|
| Placebo | Placebo Comparator | Intravenous (IV) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-3921 | Biological | Solution for infusion; Intravenous (IV) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Upper Extremity Motor Score (UEMS) | 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. | Baseline and at Day 180 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Spinal Cord Independence Measurement (SCIM) III score | The SCIM III is a comprehensive rating scale that measures the ability of patients with SCI to perform everyday tasks according to their value for the patient. The SCIM III is grouped into four subscales: Self-Care, Respiration and Sphincter Management, Mobility in Room and Toilet, and Mobility Indoors and Outdoors. The total SCIM III score ranges from 0 to 100 points, with 0 point being requiring total assistance and 100 points being completely independent. |
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Inclusion Criteria:
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:
Body mass index (BMI) <40
Exclusion Criteria:
Additional screening criteria check may apply for qualification:
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| Name | Affiliation | Role |
|---|---|---|
| Head of Medical Science | Tanabe Pharma America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Irvine | Orange | California | 92868 | United States | ||
| Tallahassee Neurological Clinic |
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| Placebo | Biological | Solution for infusion; Intravenous (IV) |
|
| Baseline and at Day 180 |
| Change in Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) score | The GRASSP measures sensorimotor and prehension function through three domains (Strength, Sensation and Prehension) which are important in describing arm and hand function. The total GRASSP score ranges from 0 to 116 points, where a higher score indicates a better outcome. | Baseline and at Day 180 |
| Change in Spinal Cord Ability Ruler (SCAR) | The SCAR measures voluntary task specific physical actions contributing to independence in ability of daily living. The SCAR uses select items from the upper limb motor assessments of the ISNCSCI and the SCIM III. | Baseline and at Day 180 |
| Proportion of responders (i.e., subjects with cutoff number or greater increase in the UEMS compared to baseline) | Baseline and at Day 180 |
| Tallahassee |
| Florida |
| 32308 |
| United States |
| Augusta University | Augusta | Georgia | 30912 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| Spectrum Health | Grand Rapids | Michigan | 49503 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Saint Louis University Hospital | St Louis | Missouri | 63110 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Carolinas Rehabilitation | Charlotte | North Carolina | 28203 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45219 | United States |
| Oregon Health and Science University - Center for Health & Healing | Portland | Oregon | 97239 | United States |
| Brooke Army Medical Center in San Antonio | Houston | Texas | 78234 | United States |
| The University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| Carilion Clinic | Roanoke | Virginia | 24014 | United States |
| Medical College of Wisconsin - Froedtert Hospital | Milwaukee | Wisconsin | 53226 | United States |
| NSHA-Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia | B3H3A7 | Canada |
| The Ottawa Hospital | Ottawa | Ontario | K1Y4E9 | Canada |
| Japan Organization of Occupational Health and Safety SPINAL INJURIES CENTER | Izuka-shi | Fukuoka | 820-8508 | Japan |
| Gifu University Hospital | Gifu | Gifu | 501-1194 | Japan |
| Hokkaido Spinal Cord Injury Center | Bibai-shi | Hokkaido | 072-0015 | Japan |
| Japanese Red Cross Kobe Hospital | Kobe | Hyōgo | 651-0073 | Japan |
| National Hospital Organization Kumamoto Medical Center | Kumamoto | Kumamoto | 860-0008 | Japan |
| Murayama Medical Center | Musashimurayama-shi | Tokyo | 208-0011 | Japan |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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