Study to Assess the Efficacy and Safety of MT-3921 in Subjects With Acute Traumatic Cervical Spinal Cord Injury
- Registration Number
- NCT04683848
- Lead Sponsor
- Mitsubishi Tanabe Pharma America Inc.
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Intravenous (IV) MT-3921 MT-3921 Intravenous (IV)
- Primary Outcome Measures
Name Time Method Change in Upper Extremity Motor Score (UEMS) Baseline and at Day 180 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.
- Secondary Outcome Measures
Name Time Method Change in Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) score Baseline and at Day 180 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.
Change in Spinal Cord Ability Ruler (SCAR) Baseline and at Day 180 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.
Change in Spinal Cord Independence Measurement (SCIM) III score Baseline and at Day 180 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.
Proportion of responders (i.e., subjects with cutoff number or greater increase in the UEMS compared to baseline) Baseline and at Day 180
Trial Locations
- Locations (23)
University of California Irvine
🇺🇸Orange, California, United States
Tallahassee Neurological Clinic
🇺🇸Tallahassee, Florida, United States
Augusta University
🇺🇸Augusta, Georgia, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Saint Louis University Hospital
🇺🇸Saint Louis, Missouri, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Atrium Health Rehabilitation & Therapy
🇺🇸Charlotte, North Carolina, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Oregon Health and Science University - Center for Health & Healing
🇺🇸Portland, Oregon, United States
Brooke Army Medical Center in San Antonio
🇺🇸Houston, Texas, United States
The University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Carilion Clinic
🇺🇸Roanoke, Virginia, United States
Medical College of Wisconsin - Froedtert Hospital
🇺🇸Milwaukee, Wisconsin, United States
NSHA-Queen Elizabeth II Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada
The Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
Japan Organization of Occupational Health and Safety SPINAL INJURIES CENTER
🇯🇵Izuka-shi, Fukuoka, Japan
Gifu University Hospital
🇯🇵Gifu-shi, Gifu, Japan
Hokkaido Spinal Cord Injury Center
🇯🇵Bibai-shi, Hokkaido, Japan
Japanese Red Cross Kobe Hospital
🇯🇵Kobe-shi, Hyogo, Japan
National Hospital Organization Kumamoto Medical Center
🇯🇵Kumamoto-shi, Kumamoto, Japan
Murayama Medical Center
🇯🇵Musashimurayama-shi, Tokyo, Japan