Study to Assess the Efficacy and Safety of MT-3921 in Subjects With Acute Traumatic Cervical Spin… (NCT04683848) | Clinical Trial Compass
CompletedPhase 2
Study to Assess the Efficacy and Safety of MT-3921 in Subjects With Acute Traumatic Cervical Spinal Cord Injury
United States72 participantsStarted 2021-08-27
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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 p…