NG004 treatment for patients with spinal cord injuries
A First-in-human (FIH) Clinical Trial to Investigate the Human Monoclonal Antibody NG004, Administrated Intrathecally in Acute Spinal Cord Injury (SCI) Patients
This study is testing a new treatment called NG004 to see if it is safe and how well it works for people who have recently suffered an incomplete cervical spinal cord injury.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 21 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | NovaGo Therapeutics AG Industry-sponsored |
| Locations | 6 sites (Bayreuth and 5 other locations) |
| Trial ID | NCT06817577 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a first-in-human, multicenter, open-label trial evaluating the safety and tolerability of NG004 in patients with acute incomplete cervical spinal cord injury. It involves multiple ascending doses to determine the maximum tolerated dose of NG004. The study focuses on patients who are 4 to 28 days post-injury and have specific neurological classifications. The trial aims to gather pharmacokinetic data alongside safety assessments.
Who should consider this trial
Good fit: Ideal candidates are adults with acute incomplete cervical spinal cord injuries classified as ASIA impairment scale C-D, occurring 4 to 28 days prior to screening.
Not a fit: Patients with complete spinal cord injuries or those with significant pre-existing systemic diseases may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could improve recovery outcomes for patients with acute spinal cord injuries.
How similar studies have performed: While this approach is novel, similar studies targeting spinal cord regeneration have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bayreuth and 5 other locations
- Klinik für Querschnittgelähmte, Klinikum Bayreuth — Bayreuth, Germany (Recruiting)
- Zentrum für Rückenmarkverletzte und Klinik für Orthopädie, BG Klinikum Bergmannstrost — Halle, Germany (Not_yet_recruiting)
- Klinik für Paraplegiologie, Universitätsklinikum Heidelberg — Heidelberg, Germany (Recruiting)
- Zentrum für Rückenmarksverletzte, Unfallklinik Murnau — Murnau am Staffelsee, Germany (Recruiting)
- Swiss Paraplegic Centre — Nottwil, Switzerland (Recruiting)
- Universitätsklinik Balgrist — Zurich, Switzerland (Recruiting)
Study contacts
- Study coordinator: Director of Clinical Research
- Email: clinical@novagotx.com
- Phone: +41433005263
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.