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Study on the Safety and Effectiveness of Elezanumab for Adults with Acute Traumatic Cervical 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 Acute Traumatic Cervical Spinal Cord Injury. The treatment being tested is called Elezanumab, which is administered as a solution through an intravenous (IV) infusion. The study also includes a comparison with a Placebo Solution for Injection or Infusion.

The purpose of the study is to evaluate the safety and effectiveness of Elezanumab in individuals who have experienced a recent injury to the cervical region of their spinal cord. Participants in the study will receive either Elezanumab or a placebo and will be monitored for changes in their upper body motor function, which refers to the movement and strength of the arms and hands. The study will track these changes over a period of time to determine the impact of the treatment.

Throughout the study, participants will undergo regular assessments to measure their progress. These assessments will include evaluations of their ability to perform daily activities independently and any improvements in their motor skills. The study aims to provide valuable insights into the potential benefits of Elezanumab for individuals with this type of spinal cord injury.

1 joining the study

Upon joining the study, informed consent must be provided. If unable to provide consent, a legally authorized representative may do so on your behalf.

Eligibility includes being an adult aged 18 to 75 with an acute traumatic cervical spinal cord injury at specific levels (C4, C5, C6, or C7).

2 initial assessment

An initial assessment will be conducted to confirm eligibility, including a neurological evaluation to determine the Upper Extremity Motor Score (UEMS) and the American Spinal Injury Association Impairment Scale (AIS) grade.

3 treatment initiation

Treatment with elezanumab or a placebo will begin within 24 hours of injury. The medication is administered through an intravenous (IV) infusion.

4 treatment period

During the treatment period, regular assessments will be conducted to monitor safety and efficacy. The primary focus is on changes in the Upper Extremity Motor Score (UEMS).

Secondary assessments include the Spinal Cord Independence Measures (SCIM III) self-care score and changes in UEMS from baseline.

5 follow-up

Follow-up assessments will continue to evaluate long-term outcomes and any potential side effects of the treatment.

Who Can Join the Study?

  • The person or their legally authorized representative must agree to participate by signing a consent form approved by an independent ethics committee or institutional review board. If the person cannot give consent, someone legally allowed to act on their behalf must do so.
  • The person must be an adult, male or female, aged between 18 and 75 years.
  • The person must have an acute traumatic cervical spinal cord injury. This means a sudden injury to the neck area of the spinal cord, specifically at the C4, C5, C6, or C7 levels, without damage to the spinal cord in the chest or lower back areas that would significantly limit recovery, according to the investigator.
  • The person must have a maximum screening UEMS of 32. UEMS stands for Upper Extremity Motor Score, which is a measure of muscle strength in the arms.
  • The person must have an AIS grade of A or B at screening. AIS stands for American Spinal Injury Association Impairment Scale, which is used to classify the severity of spinal cord injuries.
  • The person must be able to start receiving the study drug within 24 hours of the injury.
  • If the person has other health conditions, they must be stable and not expected to worsen significantly in the next 12 months, according to the investigator.

Who Cannot Join the Study?

  • Patients who have a different type of spinal cord injury that is not acute or traumatic.
  • Patients who have a spinal cord injury in a different area than the cervical (neck) region.
  • Patients who have other serious health conditions that might interfere with the study.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies or reactions to the study medication or similar drugs.
  • Patients who have a history of substance abuse or addiction.
  • Patients who have certain mental health conditions that might affect their ability to participate.
  • Patients who are taking medications that could interfere with the study treatment.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Hospital Universitario 12 De Octubre Madrid Spain
Virgen del Rocío University Hospital Sevilla Spain
Hefaugqo Vvke dfjfbvdk Barcelona Spain
Hckpirfn Umkasbccotnyr dl A Caoqya A Coruna Galicia Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
30.04.2020

Trial locations

Investigated drugs:

Elezanumab is a medication being studied for its potential to help people who have experienced a sudden injury to the cervical part of their spinal cord. The trial aims to determine if this medication is safe to use and if it can effectively aid in recovery from such injuries.

Investigated diseases:

Acute Traumatic Cervical Spinal Cord Injury – This condition occurs when there is a sudden, traumatic impact to the cervical region of the spinal cord, which is located in the neck. The injury can result in partial or complete loss of motor function and sensation in the arms, legs, and trunk, depending on the severity and location of the damage. Initially, there may be swelling and inflammation around the injury site, which can exacerbate symptoms. Over time, the body may attempt to repair the damage, but the extent of recovery can vary widely. The condition can lead to significant changes in mobility and independence, affecting daily activities and quality of life. Rehabilitation and supportive care are often necessary to help individuals adapt to changes in function.

Trial ID:
2023-505125-14-00
Protocol code:
M16-077
NCT ID:
NCT04295538
Trial Phase:
Therapeutic exploratory (Phase II)

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