NG004 in Incomplete Spinal Cord Injury Patients

NCT07840196 | Recruiting Phase 1 DMC

• 2 other identifiers: NG004-SCI-0022026-526089-26
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 10

Brief 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.

Conditions

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

Keywords

Acute spinal cord injury; Nogo-A; SPROUT-2; Regeneration

Outcome Measures

Primary Outcomes (1)

• Type, frequency, severity, and causal relationship of adverse events (AEs), serious AEs, and adverse drug reactions

  From treatment start up to 6 months

Secondary Outcomes (3)

• NG004 concentration in serum and CSF

  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

  Baseline to 6 months

• Effect on daily life functioning as Spinal Cord Independence Measure (SCIM-III)

  Month 6

Other Outcomes (9)

• Effect on Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP): strength and prehension performance

  Month 6

• Effect on the Walking Index for Spinal Cord Injury (WISCI II)

  Month 6

• Effect on 10-meter walking test (10mWT)

  Month 6

Study Arms (2)

NG004

EXPERIMENTAL

Drug: NG004

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

NG004 DRUG

repeated intrathecal injections of NG004 within 30 days

NG004

Placebo OTHER

repeated intrathecal injections of Placebo within 30 days

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NovaGo Therapeutics AG: lead

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

MeSH Terms

Conditions

Spinal Cord Diseases; Spinal Cord Injuries; Trauma, Nervous System

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries

Central Study Contacts

Director of Clinical Research

CONTACT

+41433005263; clinical@novagotx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 24, 2026
• Study Start: August 5, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (3); DE (7)