Clinical Trials for Spinal Cord Injury Cervical
There are currently 2 ongoing clinical trials investigating new treatments for people who have experienced a recent injury to the cervical (neck) region of the spinal cord. These studies are testing medications called monoclonal antibodies that may help protect nerve tissue and support recovery after injury. Trials are taking place in Germany and Spain.
Clinical trial locations
- Germany
- Spain
Study on the Safety of NG004 for Patients with Acute Spinal Cord Injury
This trial is taking place in Germany and focuses on evaluating a new treatment called NG004, which is a type of protein-based medication known as a monoclonal antibody. The study aims to understand how safe this treatment is and how well patients tolerate it when given multiple times over several weeks.
Who can participate: Adults between 18 and 70 years old who have recently experienced an incomplete cervical spinal cord injury may be eligible. An incomplete injury means that some function remains below the injury site. The first injection must be given between 4 and 28 days after the injury occurs. Participants need to be medically stable, meaning their vital signs and overall health condition are steady. Both men and women can join, but those who can have children must use reliable contraception during the study and for 6 months after the last dose. People who can breathe on their own without continuous machine support are eligible, even if they have paralysis in all four limbs.
Who cannot participate: People with a complete spinal cord injury, where there is no feeling or movement below the injury site, are not eligible. Pregnant or breastfeeding women cannot join. Anyone with other serious medical conditions that might interfere with the study or make the treatment unsafe will be excluded. People who cannot understand and agree to participate, or those taking part in another clinical trial at the same time, are also not allowed to join. Those with a history of severe allergic reactions to similar treatments cannot participate.
What the trial involves: The medication NG004 is given as an injection directly into the spinal canal, a method called intrathecal injection. Participants will receive repeated injections over a period of weeks. Throughout the study, researchers will carefully monitor for any side effects or adverse reactions. Regular assessments will include laboratory tests, heart function checks using an electrocardiogram, physical and neurological examinations, and evaluations of muscle stiffness and pain levels. The study will also measure how the body processes NG004 by checking its levels in both the blood and the cerebrospinal fluid that surrounds the brain and spinal cord. The trial is expected to run until September 2026, with participant recruitment beginning in December 2024.
Study on the Safety and Effectiveness of Elezanumab for Adults with Acute Traumatic Cervical Spinal Cord Injury
This trial is being conducted in Spain and investigates a treatment called elezanumab, which is given through an intravenous (IV) infusion directly into a vein. The study compares elezanumab with a placebo to determine both its safety and how effective it is in helping people recover after a recent cervical spinal cord injury.
Who can participate: Adults aged 18 to 75 who have experienced a sudden traumatic injury to the cervical spinal cord are eligible. Specifically, the injury must be at the C4, C5, C6, or C7 level of the spine. Participants must have an Upper Extremity Motor Score of 32 or less at the time of screening. This score measures the strength in the arms. The injury must also be classified as grade A or B on the American Spinal Injury Association Impairment Scale, which indicates the severity of the injury. Treatment must begin within 24 hours of the injury. People with other stable health conditions that are not expected to worsen significantly in the next 12 months may participate. If someone cannot provide consent themselves, a legally authorized representative can do so on their behalf.
Who cannot participate: People with a different type of spinal cord injury that is not acute or traumatic are excluded. Those with injuries in areas other than the cervical region cannot join. Pregnant or breastfeeding women are not eligible. People who have recently participated in another clinical trial, have allergies to the study medication or similar drugs, or have a history of substance abuse or addiction are excluded. Those with certain mental health conditions that might affect their ability to participate, serious health conditions that could interfere with the study, or who are taking medications that might interact with the study treatment are also not allowed to join. People unable to follow study procedures or attend required visits cannot participate.
What the trial involves: Participants will receive either elezanumab or a placebo through an IV infusion, beginning within 24 hours of their injury. Throughout the study, researchers will monitor changes in upper body motor function, particularly the movement and strength of the arms and hands. Regular assessments will track progress and measure improvements in motor skills and the ability to perform daily activities independently. The primary focus is on measuring changes in the Upper Extremity Motor Score and evaluating self-care abilities using the Spinal Cord Independence Measures. Follow-up assessments will continue to evaluate long-term outcomes and any potential side effects of the treatment.
Summary
Both ongoing trials for cervical spinal cord injury are investigating monoclonal antibodies as potential treatments for people who have recently experienced this type of injury. The trials are geographically distinct, with one taking place in Germany and the other in Spain. While both studies focus on acute injuries, they differ in their approach: the German trial examines NG004 given through intrathecal injection directly into the spinal canal, while the Spanish trial tests elezanumab delivered intravenously. Both treatments work by targeting specific proteins that may interfere with nerve repair and recovery. A key similarity is the tight timeframe for treatment initiation—both trials require treatment to begin within days to weeks of the injury, reflecting the importance of early intervention in spinal cord injury care. These studies represent important steps toward finding new ways to support recovery and improve outcomes for people with cervical spinal cord injuries.
