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Ng004

A groundbreaking clinical trial is underway to investigate the potential of NG004, a human monoclonal antibody, in treating acute spinal cord injuries. This first-in-human study aims to evaluate the safety, tolerability, and effectiveness of NG004 when administered intrathecally (directly into the spinal fluid) to patients with acute incomplete cervical spinal cord injuries. The trial will assess multiple doses of NG004 and determine the maximum tolerated dose, potentially paving the way for a new treatment option in spinal cord injury care.

Table of Contents

What is NG004?

NG004 is a new medication being studied for the treatment of acute spinal cord injury. It is classified as a human monoclonal antibody, which is a type of protein that can target specific cells or substances in the body[1]. This medication is currently undergoing clinical trials to evaluate its safety and effectiveness in patients with recent spinal cord injuries.

Medical Condition Treated by NG004

NG004 is being developed to treat acute incomplete cervical spinal cord injury. This type of injury affects the neck area of the spinal cord and is considered “incomplete,” meaning that some nerve function remains below the level of injury[1]. Specifically, the trial focuses on injuries between the C1 and C8 levels of the cervical spine.

How NG004 Works

While the exact mechanism of action is not detailed in the provided information, NG004 is administered intrathecally. This means it is injected directly into the fluid surrounding the spinal cord[1]. This method of delivery allows the medication to reach the injured area more directly, potentially improving its effectiveness.

Clinical Trial Details

The clinical trial for NG004 is a first-in-human (FIH) study, which means it’s the first time this medication is being tested in people. It is an integrated Phase I and II study, designed to evaluate both the safety and potential effectiveness of the drug[1]. Key aspects of the trial include:

  • Multiple intrathecal injections of NG004 over several weeks
  • Assessment of the drug’s safety and how well patients tolerate it
  • Evaluation of how the drug moves through and is processed by the body (pharmacokinetics)

Eligibility Criteria

The trial has specific criteria for who can participate. Some key eligibility factors include[1]:

  • Age: 18 to 70 years old
  • Recent spinal cord injury: The first treatment must be given within 4-28 days after the injury
  • Specific injury classification: Participants must have an incomplete cervical spinal cord injury classified according to the American Spinal Injury Association (ASIA) impairment scale
  • Ability to breathe: Participants should not be completely dependent on mechanical ventilation
  • Overall health: Participants must be clinically stable and free from certain other medical conditions

There are also several factors that would exclude someone from participating, such as certain types of injuries, pre-existing medical conditions, or recent participation in other clinical trials.

Safety and Monitoring

The primary focus of this trial is to assess the safety of NG004. Researchers will closely monitor[1]:

  • Any side effects or adverse events
  • Changes in laboratory tests, heart function (ECG), and vital signs
  • Physical and neurological examinations
  • Muscle spasticity and pain levels

Potential Benefits

While it’s important to note that the effectiveness of NG004 is still being studied, the hope is that this medication could potentially help improve outcomes for patients with acute spinal cord injuries. The trial will provide valuable information about the safety of the drug and how it behaves in the body, which are crucial first steps in developing a new treatment[1].

Aspect Details
Drug Name NG004
Drug Type Human Monoclonal Antibody
Administration Method Repeated intrathecal injections
Target Condition Acute incomplete cervical spinal cord injury
Primary Objectives Evaluate safety, tolerability, and pharmacokinetics; Determine maximum tolerated dose
Secondary Objectives Assess effects on motor function and daily life activities
Assessment Tools ISNCSCI, SCIM-III
Study Duration Up to 6 months from treatment start

FAQ

  • What is NG004 and how is it administered in the clinical trial? NG004 is a human monoclonal antibody being tested for the treatment of acute spinal cord injuries. In the clinical trial, it is administered through repeated intrathecal injections, which means the drug is injected directly into the fluid surrounding the spinal cord.
  • What is the main goal of this clinical trial for NG004? The main goal of this trial is to evaluate the safety, tolerability, and pharmacokinetics (how the drug moves through the body) of NG004 in patients with acute incomplete cervical spinal cord injuries. The study will also determine the maximum tolerated dose of the drug.
  • Who can participate in this NG004 clinical trial? The trial is designed for patients with acute incomplete cervical spinal cord injuries. This means the injury is recent and affects the neck area of the spinal cord, but some function below the injury level remains.
  • What outcomes will be measured in the NG004 clinical trial? The trial will measure several outcomes, including the safety profile of NG004, its concentration in the blood, its effects on motor function (particularly in the upper extremities), and its impact on daily life functioning using standardized assessments like the ISNCSCI and SCIM-III scales.
  • How long will participants be monitored in the NG004 clinical trial? Participants will be monitored for up to 6 months from the start of treatment. This extended observation period allows researchers to assess both short-term and longer-term effects of NG004 on spinal cord injury recovery.

Ongoing Clinical Trials on Ng004

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

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany

Glossary

  • Monoclonal Antibody: A type of protein made in the laboratory that can bind to substances in the body, including cancer cells. In this case, NG004 is a monoclonal antibody designed to target specific processes related to spinal cord injury.
  • Intrathecal Injection: A method of delivering medication directly into the fluid surrounding the brain and spinal cord, known as the cerebrospinal fluid.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and excreted.
  • Maximum Tolerated Dose: The highest dose of a drug that can be given without causing unacceptable side effects.
  • Acute Spinal Cord Injury (SCI): A recent injury to the spinal cord that can result in a loss of function, such as mobility or feeling.
  • Incomplete Cervical SCI: A spinal cord injury in the neck region where some function remains below the level of injury.
  • ISNCSCI: International Standards for Neurological Classification of Spinal Cord Injury, a standardized assessment to document sensory and motor impairments following spinal cord injury.
  • SCIM-III: Spinal Cord Independence Measure, version III, a scale used to assess the ability of spinal cord injury patients to perform daily life activities independently.
  • Myotome: A group of muscles innervated by a single spinal nerve root.
  • Upper Extremity Motor Score (UEMS): A part of the ISNCSCI assessment that measures arm and hand function after a spinal cord injury.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-of-ng004-for-patients-with-acute-spinal-cord-injury/