Actively Recruiting
NG004 in Spinal Cord Injury Patients
Led by NovaGo Therapeutics AG · Updated on 2025-02-10
21
Participants Needed
6
Research Sites
88 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
NG004 in Spinal Cord Injury Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Acute incomplete cervical spinal cord injury (lesion between C1 and C8) with confirmed ASIA impairment scale C-D at screening
- Injury occurred 4 to 28 days before enrollment
- Not fully dependent on mechanical ventilation
- Clinically and hemodynamically stable according to acute SCI condition at baseline
You will not qualify if you...
- Trauma caused by penetrating injuries like gunshot or knife wounds
- Multiple clinically relevant spinal cord lesions
- Major brachial or lumbar plexus damage or trauma
- Significant head trauma or injury interfering with spinal cord function assessment
- Severe pre-existing or current systemic diseases such as lung, liver (except uncomplicated Hepatitis A), gastrointestinal, cardiac, immunodeficiency including HIV, kidney disease, or active cancer
- History or recent episode of Multiple Sclerosis or Guillain-Barre syndrome
- History of meningitis or meningoencephalitis within past 6 months
- History of refractory epilepsy
- History or current autoimmune disease
- Uncontrolled bleeding disorders or need for anticoagulation not related to SCI
- Any unstable medical or psychiatric condition
- Drug dependence within 6 months before trial entry
- Pregnant or nursing women
- History of life-threatening allergic or immune reactions
- Infection around planned spinal needle insertion sites
- Participation in another clinical study within 4 weeks or longer if required
- Unconscious patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Klinik für Querschnittgelähmte, Klinikum Bayreuth
Bayreuth, Germany
Actively Recruiting
2
Zentrum für Rückenmarkverletzte und Klinik für Orthopädie, BG Klinikum Bergmannstrost
Halle, Germany
Not Yet Recruiting
3
Klinik für Paraplegiologie, Universitätsklinikum Heidelberg
Heidelberg, Germany
Actively Recruiting
4
Zentrum für Rückenmarksverletzte, Unfallklinik Murnau
Murnau am Staffelsee, Germany
Actively Recruiting
5
Swiss Paraplegic Centre
Nottwil, Switzerland
Actively Recruiting
6
Universitätsklinik Balgrist
Zurich, Switzerland
Actively Recruiting
Research Team
D
Director of Clinical Research
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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