Study to Assess the Efficacy and Safety of MT-3921 in Subjects With Acute Traumatic Cervical Spinal Cord Injury
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04683848|
Recruitment Status : Recruiting
First Posted : December 24, 2020
Last Update Posted : August 4, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Biological: MT-3921 Biological: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||August 27, 2021|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||April 2023|
Solution for infusion; Intravenous (IV)
Other Name: Unasnemab
Placebo Comparator: Placebo
Solution for infusion; Intravenous (IV)
- Change in Upper Extremity Motor Score (UEMS) [ Time Frame: 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.
- Change in Spinal Cord Independence Measurement (SCIM) III score [ Time Frame: 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.
- Change in Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) score [ Time Frame: 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) [ Time Frame: 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.
- Proportion of responders (i.e., subjects with cutoff number or greater increase in the UEMS compared to baseline) [ Time Frame: Baseline and at Day 180 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04683848
|Contact: Clinical Trials Information Desk, to prevent miscommunication,||please email:||firstname.lastname@example.org|
|Study Director:||Head of Medical Science||Mitsubishi Tanabe Pharma Development America, Inc.|