Ongoing Clinical Trials for Spinal Cord Injury
Currently, there are 2 ongoing clinical trials investigating new treatments for spinal cord injury. These trials are taking place in the Netherlands, Spain, and Portugal, testing medications aimed at improving safety, function, and recovery outcomes for individuals living with this condition.
Clinical trial locations
- Netherlands
- Portugal
- Spain
Study on Baclofen for Pulmonary and Sleep Disorders in Spinal Cord Injury Patients
This trial is investigating the safety of delivering Baclofen directly into the spinal fluid for people living with spinal cord injuries. The main focus is on ensuring that this treatment method does not negatively affect lung function or cause sleep-related breathing problems.
Who can participate:
- Adults over 18 years old with a spinal cord injury in the neck area (between C1 and Th1)
- People experiencing generalized muscle stiffness (spasticity) in their upper limbs that affects daily activities
- Those who have tried oral medications or local treatments for spasticity that either didn’t work or caused too many side effects
- Individuals whose injury occurred more than one year ago
- People with stable medical conditions who are suitable candidates for a baclofen pump implant
- Those classified as A, B, C, or D on the American Spinal Injury Association Impairment Scale
- Individuals who have not received muscle or nerve block treatments within the past 6 months
Who cannot participate:
- People with severe allergic reactions to the study medication
- Those with uncontrolled high blood pressure or recent heart attack
- Individuals with severe liver or kidney disease
- Pregnant or breastfeeding women
- People with a history of drug or alcohol abuse
- Those currently participating in another clinical trial
- Individuals with certain types of infections or cancer, or who have had recent surgery
What the trial involves:
The trial uses Baclofen, a muscle relaxant medication delivered through intrathecal administration, meaning it goes directly into the spinal fluid. This method aims to reduce muscle stiffness more effectively while minimizing side effects. Researchers will closely monitor participants’ breathing patterns, lung function, and sleep quality throughout the study. They will also assess changes in muscle stiffness, patient satisfaction, and daily functioning. The study is expected to conclude by January 2026.
Study on the Safety and Effectiveness of TZ-161 for Adults with Early Acute Spinal Cord Injury
This trial is evaluating a new medication called TZ-161 for people who have recently experienced an acute spinal cord injury. The study aims to determine whether this treatment, given alongside standard care, is safe and can improve recovery outcomes compared to standard care alone.
Who can participate:
- Adults between 18 and 65 years old
- People with a recent traumatic injury to the middle part of the spine (thoracic region, between T1 and T12)
- Individuals whose injury is suspected to be a single traumatic contusion (bruise from a blow)
- Those classified as AIS grade B, C, or D, indicating varying levels of motor and sensory function
- People with a motor score of 3 or less in at least one key muscle of a lower limb
- Those who can receive the medication within 24 hours of their injury
- Individuals who can provide informed consent and are willing to complete the study
Who cannot participate:
- People whose injury is not recent and sudden
- Those under 18 years of age
- Individuals who are part of vulnerable populations, such as those with certain disabilities or those unable to make decisions for themselves
What the trial involves:
Participants will receive TZ-161, a type of drug known as a 5-HT1 Receptor Agonist, which is believed to help with nerve repair and regeneration. The medication comes in the form of a film-coated tablet called Relert 40 mg, taken orally. Throughout the study, researchers will monitor changes in motor and sensory functions, muscle stiffness, pain levels, and hospital stay duration. Follow-up visits are scheduled at one month, three months, and six months after starting treatment. The trial will compare outcomes between those receiving TZ-161 plus standard care and those receiving only standard care. The study is expected to conclude by June 2027.
Summary
These two clinical trials represent different approaches to improving outcomes for people with spinal cord injuries. The Baclofen study focuses on long-term management of chronic symptoms, particularly muscle stiffness, in individuals who sustained their injuries more than a year ago. It emphasizes safety monitoring of respiratory function when delivering medication directly into the spinal fluid.
In contrast, the TZ-161 trial targets the very early stages after injury, aiming to intervene within 24 hours of trauma to potentially improve recovery. This early intervention approach reflects growing interest in treatments that may help nerve repair and regeneration immediately following injury.
Geographically, these trials are concentrated in Western Europe, with the Netherlands hosting the Baclofen study and Spain and Portugal participating in the TZ-161 research. Both trials demonstrate ongoing efforts to find better treatment options for individuals at different stages of living with spinal cord injury.
