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NCT07840196From ClinicalTrials.govRecruiting

NG004 in Incomplete Spinal Cord Injury Patients

A Randomized, Double-blind, Placebo Controlled Clinical Trial to Investigate the Human Monoclonal Antibody NG004 in Acute, Incomplete Cervical Spinal Cord Injury (SCI) Patients

  • Acute Spinal Cord Injury (SCI)
  • Spinal Cord Diseases
  • Spinal Cord Injuries
  • Trauma Nervous System

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
NovaGo Therapeutics AG
Enrolment target
120
Started
5 August 2026
Main results due
July 2029
Study sites
10
Registry updated
24 September 2026

Can you take part?

  • Ages 18 years to 75 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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) 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

What this study is about

In the sponsor’s own words, from the registry.

This is a randomized, double-blind, placebo controlled, multicenter trial of NG004 in patients with acute traumatic incomplete cervical SCI. The trial will evaluate the safety and tolerability, PK, and effects on motor function and daily life functioning of NG004 compared with placebo.

Study sites(10)

  • Klinik für Querschnittgelähmte, Klinikum Bayreuth

    Bayreuth, Germany

    Recruiting

  • BG Universitätsklinikum Bergmannsheil

    Bochum, Germany

    Not yet recruiting

  • Zentrum für Rückenmarkverletzte und Klinik für Orthopädie, BG Klinikum Bergmannstrost

    Halle, Germany

    Not yet recruiting

  • BG Klinikum Hamburg

    Hamburg, Germany

    Not yet recruiting

  • Klinik für Paraplegiologie, Universitätsklinikum Heidelberg

    Heidelberg, Germany

    Not yet recruiting

  • Zentrum für Rückenmarksverletzte, Unfallklinik Murnau

    Murnau am Staffelsee, Germany

    Not yet recruiting

  • BG Klinik Tübingen

    Tübingen, Germany

    Recruiting

  • REHAB Basel

    Basel, Switzerland

    Recruiting

  • Swiss Paraplegic Centre

    Nottwil, Switzerland

    Recruiting

  • Universitätsklinik Balgrist

    Zurich, Switzerland

    Recruiting

Showing 10 of 10 sites. 5 of the 10 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07840196. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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NG004 in Incomplete Spinal Cord Injury Patients | Trialion