Study to Asssess the Efficacy and Safety of MT-3921 in Subjects With Acute Traumatic Cervical Spinal Cord Injury

JRCT ID: jRCT2031210320

Registered date:16/09/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Acute Traumatic Cervical Spinal Cord Injury
• Date of first enrollment: 01/10/2021
• Target sample size: 72
• Countries of recruitment: United States of America,Japan,Canada,Japan
• Study type: Interventional
• Intervention(s): MT-3921 or placebo will be administered intravenously.

Outcome(s)

• Primary Outcome: Change from baseline at Day 180 in the UEMS of the ISNCSCI

Secondary Outcome

Change from baseline at Day 180 in the Spinal Cord Independence Measurement (SCIM) III score
Change from baseline at Day 180 in the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) score
Change from baseline at Day 180 in the Spinal Cord Ability Ruler (SCAR)
Proportion of responders at Day 180 (i.e., subjects with cutoff number or greater increase in the UEMS compared to baseline)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include 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:
a. Classified as AIS A, AIS B or AIS C
b. 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)
c. UEMS =<28 at Screening
- Body mass index (BMI) <40 kg/m2

Exclude criteria

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 Investigator, 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

Related Information

• Primary Sponsor: Kondo Kazuoki
• Secondary ID(s): NCT04683848