search
Back to results

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

Primary Purpose

Spinal Cord Injury

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MT-3921
Placebo
Sponsored by
Mitsubishi Tanabe Pharma America Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Honor Health Spine Group
  • University of Southern California - Keck School of MedicineRecruiting
  • University of California IrvineRecruiting
  • University of California, San Francisco
  • University of Colorado HospitalRecruiting
  • UCHealth Memorial HospitalRecruiting
  • Yale MedicineRecruiting
  • George Washington University Hospital
  • Tallahassee Neurological ClinicRecruiting
  • University of South Florida, Tampa General HospitalRecruiting
  • Shepherd CenterRecruiting
  • Augusta UniversityRecruiting
  • Memorial Health University Medical CenterRecruiting
  • OSF Saint Francis Medical CenterRecruiting
  • Carle Foundation Hospital
  • University of KentuckyRecruiting
  • Louisiana State University Health Sciences CenterRecruiting
  • Insight Institute of Neurosurgery & Neuroscience
  • Spectrum HealthRecruiting
  • Hennepin County Medical CenterRecruiting
  • Mayo ClinicRecruiting
  • University of Mississippi Medical CenterRecruiting
  • Saint Louis University HospitalRecruiting
  • Washington University School of MedicineRecruiting
  • University of Nebraska Medical CenterRecruiting
  • Kessler Institute for Rehabilitation
  • Albany Medical Center
  • Nassau University Medical Center
  • NYC Health Hospital - ElmhurstRecruiting
  • Mount Sinai MorningsideRecruiting
  • Stony Brook University HospitalRecruiting
  • Atrium Health Rehabilitation & TherapyRecruiting
  • Vidant Medical CenterRecruiting
  • University of CincinnatiRecruiting
  • The Ohio State University Wexner Medical Center
  • Mercy Health St. Vincent Medical CenterRecruiting
  • Ascension St. JohnRecruiting
  • Oregon Health and Science University - Center for Health & HealingRecruiting
  • Penn Presbyterian Medical CenterRecruiting
  • Thomas Jefferson UniversityRecruiting
  • University of Pittsburgh Medical Center - PresbyterianRecruiting
  • Regional One HealthRecruiting
  • Baylor Scott & White Institute for RehabilitationRecruiting
  • UT Southwestern Medical CenterRecruiting
  • JPS Health NetworkRecruiting
  • TIRR Memorial Hermann UT HealthRecruiting
  • Brooke Army Medical Center in San AntonioRecruiting
  • The University of Texas Health Science Center at San AntonioRecruiting
  • Carilion ClinicRecruiting
  • Medical College of Wisconsin - Froedtert HospitalRecruiting
  • University of Calgary Foothills Medical CentreRecruiting
  • NSHA-Queen Elizabeth II Health Sciences CentreRecruiting
  • The Ottawa HospitalRecruiting
  • Toronto Western HospitalRecruiting
  • University of SaskatchewanRecruiting
  • Funabashi Municipal Medical CenterRecruiting
  • Japan Organization of Occupational Health and Safety SPINAL INJURIES CENTERRecruiting
  • Gifu University HospitalRecruiting
  • Hokkaido Spinal Cord Injury CenterRecruiting
  • Japanese Red Cross Kobe HospitalRecruiting
  • National Hospital Organization Kumamoto Medical CenterRecruiting
  • Murayama Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MT-3921

Placebo

Arm Description

Intravenous (IV)

Intravenous (IV)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Proportion of responders (i.e., subjects with cutoff number or greater increase in the UEMS compared to baseline)

Full Information

First Posted
December 20, 2020
Last Updated
September 14, 2023
Sponsor
Mitsubishi Tanabe Pharma America Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04683848
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 27, 2021 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma America Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MT-3921
Arm Type
Experimental
Arm Description
Intravenous (IV)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intravenous (IV)
Intervention Type
Biological
Intervention Name(s)
MT-3921
Other Intervention Name(s)
Unasnemab
Intervention Description
Solution for infusion; Intravenous (IV)
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Solution for infusion; Intravenous (IV)
Primary Outcome Measure Information:
Title
Change in Upper Extremity Motor Score (UEMS)
Description
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.
Time Frame
Baseline and at Day 180
Secondary Outcome Measure Information:
Title
Change in Spinal Cord Independence Measurement (SCIM) III score
Description
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.
Time Frame
Baseline and at Day 180
Title
Change in Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) score
Description
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.
Time Frame
Baseline and at Day 180
Title
Change in Spinal Cord Ability Ruler (SCAR)
Description
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.
Time Frame
Baseline and at Day 180
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trials Information Desk, to prevent miscommunication,
Phone
please email:
Email
information@mt-pharma-us.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Head of Medical Science
Organizational Affiliation
Mitsubishi Tanabe Pharma America Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Honor Health Spine Group
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Southern California - Keck School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
UCHealth Memorial Hospital
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Individual Site Status
Recruiting
Facility Name
Yale Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Individual Site Status
Recruiting
Facility Name
George Washington University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
22037
Country
United States
Individual Site Status
Withdrawn
Facility Name
Tallahassee Neurological Clinic
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Individual Site Status
Recruiting
Facility Name
University of South Florida, Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Name
Shepherd Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Individual Site Status
Recruiting
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Health University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Individual Site Status
Recruiting
Facility Name
OSF Saint Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Individual Site Status
Recruiting
Facility Name
Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Name
Louisiana State University Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Name
Insight Institute of Neurosurgery & Neuroscience
City
Flint
State/Province
Michigan
ZIP/Postal Code
48507
Country
United States
Individual Site Status
Withdrawn
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Recruiting
Facility Name
Saint Louis University Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Recruiting
Facility Name
Kessler Institute for Rehabilitation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Nassau University Medical Center
City
East Meadow
State/Province
New York
ZIP/Postal Code
11554
Country
United States
Individual Site Status
Withdrawn
Facility Name
NYC Health Hospital - Elmhurst
City
Elmhurst
State/Province
New York
ZIP/Postal Code
11373
Country
United States
Individual Site Status
Recruiting
Facility Name
Mount Sinai Morningside
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Individual Site Status
Recruiting
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Name
Atrium Health Rehabilitation & Therapy
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Individual Site Status
Recruiting
Facility Name
Vidant Medical Center
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Mercy Health St. Vincent Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Individual Site Status
Recruiting
Facility Name
Ascension St. John
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Individual Site Status
Recruiting
Facility Name
Oregon Health and Science University - Center for Health & Healing
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Name
Penn Presbyterian Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pittsburgh Medical Center - Presbyterian
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Name
Regional One Health
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Individual Site Status
Recruiting
Facility Name
Baylor Scott & White Institute for Rehabilitation
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Name
JPS Health Network
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Name
TIRR Memorial Hermann UT Health
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Brooke Army Medical Center in San Antonio
City
Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Carilion Clinic
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical College of Wisconsin - Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Calgary Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N2T9
Country
Canada
Individual Site Status
Recruiting
Facility Name
NSHA-Queen Elizabeth II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H3A7
Country
Canada
Individual Site Status
Recruiting
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y4E9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T2S8
Country
Canada
Individual Site Status
Recruiting
Facility Name
University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N0W8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Funabashi Municipal Medical Center
City
Funabashi-shi
State/Province
Chiba
ZIP/Postal Code
273-0853
Country
Japan
Individual Site Status
Recruiting
Facility Name
Japan Organization of Occupational Health and Safety SPINAL INJURIES CENTER
City
Izuka-shi
State/Province
Fukuoka
ZIP/Postal Code
820-8508
Country
Japan
Individual Site Status
Recruiting
Facility Name
Gifu University Hospital
City
Gifu-shi
State/Province
Gifu
ZIP/Postal Code
501-1194
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hokkaido Spinal Cord Injury Center
City
Bibai-shi
State/Province
Hokkaido
ZIP/Postal Code
072-0015
Country
Japan
Individual Site Status
Recruiting
Facility Name
Japanese Red Cross Kobe Hospital
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
651-0073
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Kumamoto Medical Center
City
Kumamoto-shi
State/Province
Kumamoto
ZIP/Postal Code
860-0008
Country
Japan
Individual Site Status
Recruiting
Facility Name
Murayama Medical Center
City
Musashimurayama-shi
State/Province
Tokyo
ZIP/Postal Code
208-0011
Country
Japan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs