Study to Assess the Efficacy and Safety of MT-3921 in Subjects With Acute Traumatic Cervical Spinal Cord Injury
Sponsored by Mitsubishi Tanabe Pharma America Inc.
About this trial
Last updated 2 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended a year ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
- Provide written informed consent prior to beginning any study procedures
- Cervical spinal cord injury that meet all of the following criteria:
- Body mass index (BMI) <40
Exclusion Criteria
- 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