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Spinal injection antibody tested for movement recovery after neck injury

NCT ID NCT07840196

Disease control Sponsor: NovaGo Therapeutics AG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 24, 2026 · Last updated Sep 25, 2026 · Updated 1 time

Summary

Researchers are testing an experimental antibody called NG004 in adults who have a recent, incomplete cervical spinal cord injury from trauma. Participants receive repeated injections of NG004 or a placebo into the fluid around the spinal cord within 30 days of injury. The trial measures safety and side effects, how the body processes the antibody, and whether it improves arm and hand movement or daily functioning compared with placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NG004, an experimental human monoclonal antibody given by repeated injections into the spinal fluid
What this could lead to
If NG004 proves safe and shows signs of helping movement, it could become a new treatment option for people with recent incomplete cervical spinal cord injuries.
What could go wrong
This is an early Phase 1 trial with 120 participants, so its main goal is safety, not proof of benefit. The antibody may cause side effects, and any improvements in movement could turn out to be small or not clearly better than placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

nervous system injury spinal cord disorder spinal cord injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute spinal cord injury (SCI) Spinal cord diseases Spinal cord injuries Trauma nervous system

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • BG Klinik Tübingen

    RECRUITING

    Tübingen, Germany

  • BG Klinikum Hamburg

    NOT_YET_RECRUITING

    Hamburg, Germany

  • BG Universitätsklinikum Bergmannsheil

    NOT_YET_RECRUITING

    Bochum, Germany

  • Klinik für Paraplegiologie, Universitätsklinikum Heidelberg

    NOT_YET_RECRUITING

    Heidelberg, Germany

  • Klinik für Querschnittgelähmte, Klinikum Bayreuth

    RECRUITING

    Bayreuth, Germany

  • REHAB Basel

    RECRUITING

    Basel, Switzerland

  • Swiss Paraplegic Centre

    RECRUITING

    Nottwil, Switzerland

  • Universitätsklinik Balgrist

    RECRUITING

    Zurich, Switzerland

  • Zentrum für Rückenmarksverletzte, Unfallklinik Murnau

    NOT_YET_RECRUITING

    Murnau am Staffelsee, Germany

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

    NOT_YET_RECRUITING

    Halle, Germany

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