NG004 for incomplete cervical spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled study conducted at multiple centers. It investigates safety, tolerability, pharmacokinetics, and effects on motor function and daily living when NG004 is given after acute incomplete cervical SCI. Eligible participants are adults with AIS B, C, or D injury between 4 and 28 days post-injury, who are hemodynamically stable and not fully dependent on mechanical ventilation. The study excludes penetrating spinal cord injuries, extensive multi-level lesions, significant head trauma, or other conditions that could interfere with assessment. Primary and secondary outcomes focus on safety and functional recovery related to spinal cord regeneration pathways involving Nogo-A and SPROUT-2."

Why it matters

Who can join: the full rules

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) B, C and D at Screening
* 4-28 days post-injury and no earlier than 4 days after spinal surgery
* No required mechanical ventilation or patients that do 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
* History of or an episode of multiple sclerosis or Guillain-Barre syndrome
* History of recent meningitis or meningoencephalitis
* History of refractory epilepsy
* 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 within the last 6 months before Screening
* Pregnant or nursing women
* History of a life-threatening allergic or immune-mediated reaction
* 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 it's running

• Klinik für Querschnittgelähmte, Klinikum Bayreuth
  Bayreuth, Germany Recruiting
• Klinik für Paraplegiologie, Universitätsklinikum Heidelberg
  Heidelberg, Germany Recruiting
• Zentrum für Rückenmarksverletzte, Unfallklinik Murnau
  Murnau am Staffelsee, Germany Recruiting
• BG Klinik Tübingen
  Tübingen, Germany Recruiting
• REHAB Basel
  Basel, Switzerland Recruiting
• Swiss Paraplegic Centre
  Nottwil, Switzerland Recruiting

Study contacts

• Study coordinator: Director of Clinical Research
• Email: clinical@novagotx.com
• Phone: +41433005263

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.