Spinal Cord Injury Trial (Sponsor: Mitsubishi)
Posted Date: Jun 14, 2021
- Investigator: Justin Virojanapa
- Specialties: Emergency Medicine, Neurology, Neurosurgery
- Type of Study: Drug
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. This study investigates whether a study medication aimed at enhancing neurite growth could improve outcomes for patients with spinal cord injury. It involves 7 intravenous infusions over 5 months, with the first infusion to take place within 48 hours of the time of spinal cord injury. Each patient will be in the study for 9 months.
Potential Participants Will Have Sustained A Spinal Cord Injury Between C4 And C7 (Classified As Ais A, B, Or C) Within The Last 48 Hours. They Must Be Age 18-70, With A Body Mass Index <40 Kg/M2, And Able To Participate In The Study For 9 Months. Those With Injury Classified As Ais D Or E Are Not Eligible, Nor Are Patients With Complete Spinal Transection, Penetrating Spinal Cord Injury, Or Those Who Are Highly Anticipated To Be Dependent On Long-Term Mechanical Ventilation (E.G. Beyond 10-14 Days), Which Would Interfere With Study Procedures. Additional Eligibility Requirements Apply.
Spinal Cord Injury, Acute, Cervical
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