Acute Spinal Cord Injury (SCI)Phase 1SPROUT-2NCT07840196
NG004 in Incomplete Spinal Cord Injury Patients
A Phase 1 study testing NG004 in people with Acute Spinal Cord Injury (SCI) and Spinal Cord Diseases, run by NovaGo Therapeutics AG at 10 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Spinal Cord Injury (SCI), Spinal Cord Diseases, Spinal Cord Injuries
- What is being tested?
- NG004
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 5 Aug 2026to Jul 2029
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 2 countries
Germany7 sites, 7 recruiting
- Recruiting
Klinik für Querschnittgelähmte, Klinikum Bayreuth
Bayreuth
qs-studien@klinikum-bayreuth.de
- Not yet recruiting
BG Universitätsklinikum Bergmannsheil
Bochum
- Not yet recruiting
Zentrum für Rückenmarkverletzte und Klinik für Orthopädie, BG Klinikum Bergmannstrost
Halle
- Not yet recruiting
BG Klinikum Hamburg
Hamburg
- Recruiting
Klinik für Paraplegiologie, Universitätsklinikum Heidelberg
Heidelberg
NISCI.OUK@med.uni-heidelberg.de
- Recruiting
Zentrum für Rückenmarksverletzte, Unfallklinik Murnau
Murnau am Staffelsee
MNU_SPROUT@bgu-murnau.de
- Recruiting
BG Klinik Tübingen
Tübingen
SPROUT@bgu-tuebingen.de
Switzerland3 sites, 3 recruiting
- Recruiting
REHAB Basel
Basel
sprout-Studienteam@rehab.ch
- Recruiting
Swiss Paraplegic Centre
Nottwil
sprout@paraplegie.ch
- Recruiting
Universitätsklinik Balgrist
Zurich
sprout@balgrist.ch
About this study
Official title: A Randomized, Double-blind, Placebo Controlled Clinical Trial to Investigate the Human Monoclonal Antibody NG004 in Acute, Incomplete Cervical Spinal Cord Injury (SCI) Patients
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.
- Conditions
- Acute Spinal Cord Injury (SCI), Spinal Cord Diseases, Spinal Cord Injuries, Trauma Nervous System
- Being tested
- NG004, Placebo
- Keywords
- Acute spinal cord injury, Nogo-A, SPROUT-2, Regeneration
- Medical subject headings
- Spinal Cord Diseases, Spinal Cord Injuries, Trauma, Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NG004Drug
repeated intrathecal injections of NG004 within 30 days
PlaceboOther
repeated intrathecal injections of Placebo within 30 days
| Study group | Role | What they receive |
|---|---|---|
| NG004 | Experimental | Not described Receives: Drug: NG004 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type, frequency, severity, and causal relationship of adverse events (AEs), serious AEs, and adverse drug reactions
Measured: From treatment start up to 6 months
Secondary outcomes (3)
NG004 concentration in serum and CSF
Measured: From treatment start up to 6 months
Effect on neurological recovery according to the International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol as change in ISNCSCI upper extremities motor score (UEMS) and Integrated Neurological Change Score
The ISNCSCI bilateral Upper Extremity Motor Score (UEMS) is determined by examining the muscle function within each of the 5 myotomes encompassing arm and hand function on each side of the body. A score ranging from 0 to 5 can be given to each myotome tested resulting in a maximum score of 50. Higher values indicate better recovery
Measured: Baseline to 6 months
Effect on daily life functioning as Spinal Cord Independence Measure (SCIM-III)
The SCIM III questionnaire self-care score assesses activities of daily living including feeding, bathing, dressing, and grooming. The self-care score ranges 0-20. The higher scores correspond to better ability to carry out the self-care activities.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start5 Aug 2026
- Primary completionJul 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Spinal Cord Injury (SCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NovaGo Therapeutics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840196
- Sponsor's protocol ID
- NG004-SCI-002
- Other IDs
- 2026-526089-26
- Acronym
- SPROUT-2
- Status last verified
- Oct 2026
- First submitted
- 7 Sep 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No