Study on the Safety of NG004 for Patients with Acute Spinal Cord Injury

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What is this study about?

This clinical trial is focused on studying a condition known as Acute Spinal Cord Injury, specifically when it affects the neck area, which is referred to as cervical spinal cord injury. The trial is investigating a new treatment using a human monoclonal antibody called NG004. Monoclonal antibodies are proteins made in a lab that can bind to substances in the body, including those that might be causing disease. In this study, NG004 is given as a solution for injection directly into the spinal canal, a method known as intrathecal use.

The purpose of the study is to evaluate the safety and tolerability of repeated injections of NG004 in patients who have recently experienced an acute spinal cord injury. Participants in the study will receive these injections over a period of several weeks. The study will monitor the type, frequency, and severity of any side effects or adverse reactions that may occur. Additionally, the study will assess various health indicators such as laboratory tests, heart function through an ECG (electrocardiogram), vital signs, physical and neurological examinations, muscle stiffness, and pain levels.

Throughout the study, researchers will also measure the levels of NG004 in the blood and in the cerebrospinal fluid, which is the fluid surrounding the brain and spinal cord. This will help determine how the body processes the medication. The trial is expected to continue until September 2026, with recruitment of participants starting in December 2024. The findings from this study will contribute to understanding the potential of NG004 as a treatment for acute spinal cord injuries.

1 eligibility confirmation

Eligibility for the trial is confirmed within 4 to 28 days after the spinal cord injury.

The patient must meet specific criteria, including age, type of injury, and health stability.

2 initial treatment

The first dose of the medication, NG004, is administered as a solution for injection.

The injection is given intrathecally, which means it is delivered into the space around the spinal cord.

3 repeated injections

The treatment involves repeated intrathecal injections of NG004 over a period of weeks.

The frequency and total number of injections are determined by the trial protocol.

4 monitoring and assessments

Throughout the trial, the patient undergoes regular monitoring to assess safety and tolerability.

This includes checking for any adverse events, conducting laboratory tests, and performing physical and neurological examinations.

5 completion of trial

The trial is expected to conclude by September 30, 2026.

Upon completion, the patient’s participation in the trial ends, and any necessary follow-up is conducted.

Who Can Join the Study?

Both male and female patients can participate.
The patient must be able to understand the nature and consequences of the trial.
Participants should be between 18 to 70 years old.
The patient must have an acute incomplete cervical spinal cord injury, which means an injury in the neck area of the spine that is not fully complete, with specific criteria for the level of injury.
The trial treatment should start with the first injection within 4 to 28 days after the injury.
Patients with tetraplegia (paralysis of all four limbs) can participate if they do not need a machine to help them breathe all the time and can breathe on their own to some extent.
The patient must be hemodynamically and clinically stable, meaning their vital signs and overall health should be stable according to their condition.
Patients who can have children must use a reliable method of contraception during the trial and for at least 6 months after the last dose. This includes various methods like hormonal contraception, intrauterine devices, or having a partner who has had a vasectomy. Women who cannot have children due to surgery or menopause are also eligible.
The patient must provide written informed consent, or a witness can provide it if the patient can only consent verbally, before joining the trial.
The patient must be willing to cooperate and complete all parts of the trial.

Who Cannot Join the Study?

Patients with a complete cervical spinal cord injury cannot participate. A complete injury means there is no feeling or movement below the injury site.
Patients who have had a spinal cord injury for more than a certain number of weeks are not eligible. The study focuses on acute injuries, which are recent injuries.
Individuals with other serious medical conditions that could affect the study results are excluded. This includes conditions that might interfere with the treatment or make it unsafe.
Patients who are unable to give informed consent, meaning they cannot understand the study and agree to participate, are not allowed to join.
Pregnant or breastfeeding women are not eligible to participate in the study.
Individuals who are participating in another clinical trial at the same time are excluded to avoid interference with the study results.
Patients with a history of severe allergic reactions to similar treatments are not eligible, as this could pose a risk to their health.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
BG Unfallklinik Murnau gGmbH	Murnau A. Staffelsee	Germany
BG Klinikum Bergmannstrost Halle gGmbH	Halle (Saale)	Germany
Ubfwvaofcqdaystueti Hdslcljxscl Kpxdbv fxg Pveughhvathukvi &guqurp Qqdnsmdyirnopabrdq	Heidelberg	Germany
Kxfwbmeh Blcwbzfd Gfpw	Bayreuth	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	01.12.2024

Trial locations

Investigated drugs:

Ng004

NG004 is a human monoclonal antibody being tested for its safety and tolerability in patients with acute spinal cord injury. It is administered directly into the spinal canal through intrathecal injections. The goal of this trial is to determine how well patients tolerate repeated doses of this antibody and to monitor any potential side effects.

Investigated diseases:

Spinal cord injury cervical

Acute Incomplete Cervical Spinal Cord Injury – This condition occurs when there is a partial injury to the spinal cord in the neck region, which can disrupt the transmission of nerve signals between the brain and the rest of the body. The injury may result in varying degrees of motor and sensory function loss below the level of the injury. Patients may experience weakness, reduced sensation, or paralysis in the arms and legs, depending on the severity and location of the injury. Over time, some individuals may regain certain functions as swelling decreases and the spinal cord begins to heal. However, the extent of recovery can vary widely among individuals. The condition requires careful management to prevent further damage and to support recovery.

Trial ID:

2024-514303-34-00

Protocol code:

NG004-SCI-001

NCT ID:

NCT06817577

Trial Phase:

Human Pharmacology (Phase I) – First administration to humans

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Study on the Safety of NG004 for Patients with Acute Spinal Cord Injury

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?