Study on the Safety and Effectiveness of TZ-161 for Adults with Early Acute Spinal Cord Injury

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for early acute spinal cord injury. The treatment being tested is a medication known by the code name TZ-161, which is a type of drug called a 5-HT1 Receptor Agonist. This medication is being compared to the standard care that patients with spinal cord injuries typically receive.

The purpose of the study is to evaluate how safe and tolerable the new treatment is, as well as how effective it might be in improving the condition of patients with spinal cord injuries. Participants in the study will receive either the new treatment along with standard care or just the standard care alone. The study will monitor changes in the participants’ motor and sensory functions, which are important for movement and feeling, over a period of time.

Throughout the study, researchers will observe the participants to see if there are any side effects from the treatment and how the treatment affects their recovery. The study will also look at how long participants need to stay in the hospital and in intensive care. This information will help determine if the new treatment can offer benefits beyond the current standard care for people with spinal cord injuries.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, type of spinal cord injury, and ability to provide informed consent.

The study is designed for individuals aged 18-65 with a specific type of spinal cord injury located in the thoracic region.

2 initial assessment

An initial assessment is conducted to evaluate the condition and establish a baseline for future comparisons.

This includes measuring motor and sensory functions using the ASIA Impairment Scale.

3 treatment administration

The treatment involves the administration of the investigational medication, referred to as IMP, in combination with standard care (SOC).

The medication is administered orally in the form of a film-coated tablet called Relert 40 mg.

4 monitoring and follow-up

Regular follow-up visits are scheduled to monitor the patient’s progress and any side effects.

These visits occur at one month (M1), three months (M3), and six months (M6) after the start of treatment.

5 evaluation of outcomes

The primary focus is on the safety and tolerability of the treatment, as well as its effectiveness in improving motor and sensory functions.

Secondary outcomes include changes in muscle spasticity and pain, as well as the length of hospital stay.

6 completion of the study

The study is expected to conclude by June 2027, with all data collected and analyzed to determine the overall effectiveness and safety of the treatment.

Who Can Join the Study?

Participants must be between 18 and 65 years old.
Participants must have a clinical diagnosis of an early acute spinal cord injury (SCI), which means a recent injury to the spinal cord.
The injury must be located in the thoracic region, which is the middle part of the spine, between T1 and T12.
The injury should be suspected to be a single traumatic contusion, which is a bruise or damage caused by a blow.
Participants must have an AIS grade of B, C, or D. The AIS (American Spinal Injury Association Impairment Scale) is a system used to describe the severity of a spinal cord injury. Grades B, C, and D indicate varying levels of motor and sensory function.
Participants must have a motor score of 3 or less in at least one key muscle of a lower limb. This score measures muscle strength.
The time from injury to drug administration must be 24 hours or less.
Participants must be willing and able to provide informed consent, which means they understand the study and agree to participate.
Participants must be willing and able to complete the study and follow the instructions given by the researchers.

Who Cannot Join the Study?

Patients who do not have an early acute spinal cord injury cannot participate. This means the injury must be recent and sudden.
Patients who are not adults cannot participate. This means you must be 18 years or older.
Patients who are part of a vulnerable population cannot participate. This refers to groups of people who might need special protection in research, like those with certain disabilities or those who cannot make decisions for themselves.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Fvbgcxrvd Pzfn Lf Irflviuwakgbc Bpssrjlnj Dox Hderhxrc Udolarkutmoiz Le Pqz	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Portugal	Not yet recruiting	01.06.2024
Spain	Recruiting	01.06.2024

Trial locations

Investigated drugs:

Eletriptan

TZ-161 is an investigational medication being studied for its potential to help people with early acute spinal cord injury. The trial aims to see if this medication is safe and well-tolerated by patients. Researchers are also looking at whether it can improve motor and sensory functions in people who have recently experienced a spinal cord injury.

SOC (Standard of Care) refers to the usual treatment that patients with early acute spinal cord injury receive. This can include various therapies and medications that are commonly used to manage symptoms and support recovery. In this trial, SOC is used as a comparison to see if adding TZ-161 provides any additional benefits.

Investigated diseases:

Spinal cord injury

Early Acute Spinal Cord Injury – This condition occurs when there is a sudden, traumatic impact on the spine that fractures or dislocates vertebrae, leading to damage to the spinal cord. The injury can disrupt the communication between the brain and the rest of the body, affecting motor and sensory functions. Initially, there may be swelling and inflammation around the injury site, which can worsen the damage. Symptoms can include loss of movement, sensation, or reflexes below the level of injury. Over time, the body may attempt to repair itself, but the extent of recovery can vary. The progression of the injury can lead to long-term changes in mobility and sensation.

Trial ID:

2023-509207-33-01

Protocol code:

TZ-161-101

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effectiveness of TZ-161 for Adults with Early Acute Spinal Cord Injury

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?