NG004 in Spinal Cord Injury Patients

Launched by NOVAGO THERAPEUTICS AG · Feb 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called NG004 for patients who have experienced an acute incomplete cervical spinal cord injury (SCI). The goal is to find out if NG004 is safe and how well it works, as well as to determine the highest dose that can be given without causing serious side effects. The trial is currently recruiting participants aged between 18 and 75 years who have had their injury within the last 4 to 28 days and are stable enough to take part.

To be eligible for this trial, participants must have a specific type of spinal cord injury that meets certain medical criteria and should not have any major complications or other serious health issues that might interfere with the study. Those who join the trial will receive different doses of NG004 through a method called intrathecal injection, which involves administering the treatment directly into the spinal canal. Throughout the study, participants will be monitored closely for their safety and wellbeing. This trial is an important step in developing potential new treatments for spinal cord injuries, and every participant will contribute valuable information to this research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Acute incomplete cervical SCI (Neurological level of injury C1 ≤ lesion ≤ C8) with confirmed classification of American Spinal Injury Association (ASIA) impairment scale (AIS) C-D at Screening
• • 4-28 days post-injury
• • No required mechanical ventilation or patients that not completely depend on mechanical ventilation
• • Hemodynamically and clinical stable patient according to the acute SCI condition at baseline
• Exclusion Criteria:
• • Trauma caused by ballistic or other injury that directly penetrates the spinal cord including gunshot and knife wounds
• • Multiple levels of clinically relevant spinal cord lesions
• • Major brachial or lumbar plexus damage/trauma
• • Significant head trauma or other injury that was, in the opinion of the investigator, sufficient to interfere with the assessment of the spinal cord function
• • Other significant pre-existing or current severe systemic disease such as lung, liver (exception: history of uncomplicated Hepatitis A), gastrointestinal, cardiac, immunodeficiency (including anamnestic known HIV) or kidney disease; or active malignancy
• • History of or an acute episode of Multiple Sclerosis or Guillain-Barre syndrome History of recent (6 months) meningitis or meningoencephalitis
• • History of refractory epilepsy
• • History of or current autoimmune disease
• • Patients with uncontrolled bleeding diathesis and/or who require concomitant therapeutic anticoagulation and not related to SCI
• • Presence of any unstable medical or psychiatric condition
• • Drug dependence any time during the 6 month's preceding trial entry
• • Pregnant or nursing women
• • History of a life-threatening allergic or immune mediated reaction
• • Patients with the presence of infection around the location where the spinal needle insertions are planned for applying the intrathecal injections
• • Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations
• • Patients who are unconscious