NG004 in Spinal Cord Injury Patients

NCT06817577 | Recruiting Phase 1 DMC

• 2 other identifiers: NG004-SCI-0012024-514303-34-00
• Study Type: interventional
• Target: 21
• Locations: 2 countries
• Sites: 6

Brief Summary

This is the FIH, multicenter, open-label, sequential, multiple ascending dose trial of NG004 in patients with acute incomplete cervical SCI. The trial will evaluate the safety, tolerability, and PK of 4 dose regimens of NG004, and will evaluate the maximum tolerated dose of NG004.

Conditions

Acute Spinal Cord Injury (SCI); Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Injuries (SCI); Wounds and Injuries

Keywords

Acute spinal cord injury; Nogo-A; SPROUT; 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 (2)

• Maximum Plasma Concentration [Cmax] in serum

  After first and last intrathecal injection, measured at pre-dose and 1, 3, 6, 24, 48 hours post-dose.

• Half-life in serum [T1/2]

  After last intrathecal injection up to 6 months

Other Outcomes (2)

• Effect on motor function as Change from Baseline in ISNCSCI upper extremities motor score (UEMS), according to the International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol

  Baseline up to 6 months

• Effect on daily life functioning according to change in Version III of the Spinal Cord Independence Measure (SCIM-III)

  Baseline to 6 months

Study Arms (1)

NG004

EXPERIMENTAL

Drug: NG004

Interventions

NG004 DRUG

repeated intrathecal injections of NG004

NG004

Eligibility Criteria

• Age: 18 Years - 70 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) C-D at Screening
• days post-injury
• No required mechanical ventilation or patients that 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 such as lung, liver (exception: history of uncomplicated Hepatitis A), gastrointestinal, cardiac, immunodeficiency (including anamnestic known HIV) or kidney disease; or active malignancy
• History of or an acute episode of Multiple Sclerosis or Guillain-Barre syndrome History of recent (6 months) meningitis or meningoencephalitis
• History of refractory epilepsy
• History of or current autoimmune disease
• 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 during the 6 month's preceding trial entry
• Pregnant or nursing women
• History of a life-threatening allergic or immune mediated reaction
• Patients with the 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 (6)

Klinik für Querschnittgelähmte, Klinikum Bayreuth

Bayreuth, Germany

RECRUITING

Zentrum für Rückenmarkverletzte und Klinik für Orthopädie, BG Klinikum Bergmannstrost

Halle, Germany

NOT YET RECRUITING

Klinik für Paraplegiologie, Universitätsklinikum Heidelberg

Heidelberg, Germany

RECRUITING

Zentrum für Rückenmarksverletzte, Unfallklinik Murnau

Murnau am Staffelsee, Germany

RECRUITING

Swiss Paraplegic Centre

Nottwil, Switzerland

RECRUITING

Universitätsklinik Balgrist

Zurich, Switzerland

RECRUITING

MeSH Terms

Conditions

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Injuries; Wounds and Injuries

Study Officials

• Director of Clinical Research

  NovaGo Therapeutics AG

  STUDY DIRECTOR

Central Study Contacts

Director of Clinical Research

CONTACT

+41433005263; clinical@novagotx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: February 10, 2025
• Study Start: December 18, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4); CH (2)