Clinical trial NCT04683848: Study to Assess the Efficacy and Safety of MT-3921 in Subjects With Acute Traumatic Cervical Spinal Cord Injury
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Spinal Cord Injury
Lead sponsor: Mitsubishi Tanabe Pharma America Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-24
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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:

  * 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 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 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

Primary outcomes:
measure: Change in Upper Extremity Motor Score (UEMS)
timeFrame: Baseline and at Day 180
Secondary outcomes:
measure: Change in Spinal Cord Independence Measurement (SCIM) III score
timeFrame: Baseline and at Day 180
measure: Change in Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) score
timeFrame: Baseline and at Day 180
measure: Change in Spinal Cord Ability Ruler (SCAR)
timeFrame: Baseline and at Day 180
measure: Proportion of responders (i.e., subjects with cutoff number or greater increase in the UEMS compared to baseline)
timeFrame: Baseline and at Day 180
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California Irvine
state: California
city: Tallahassee
country: United States
facility: Tallahassee Neurological Clinic
state: Florida
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Saint Louis
country: United States
facility: Saint Louis University Hospital
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Charlotte
country: United States
facility: Atrium Health Rehabilitation & Therapy
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University - Center for Health & Healing
state: Oregon
city: Houston
country: United States
facility: Brooke Army Medical Center in San Antonio
state: Texas
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin - Froedtert Hospital
state: Wisconsin
city: Halifax
country: Canada
facility: NSHA-Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Izuka-shi
country: Japan
facility: Japan Organization of Occupational Health and Safety SPINAL INJURIES CENTER
state: Fukuoka
city: Gifu-shi
country: Japan
facility: Gifu University Hospital
state: Gifu
city: Bibai-shi
country: Japan
facility: Hokkaido Spinal Cord Injury Center
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Japanese Red Cross Kobe Hospital
state: Hyogo
city: Kumamoto-shi
country: Japan
facility: National Hospital Organization Kumamoto Medical Center
state: Kumamoto
city: Musashimurayama-shi
country: Japan
facility: Murayama Medical Center
state: Tokyo
Study officials:
affiliation: Mitsubishi Tanabe Pharma America Inc.
name: Head of Medical Science
role: STUDY_DIRECTOR
References: