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New treatment option for Acute Spinal Cord Injury (SCI)
Official title NG004 in Spinal Cord Injury Patients
ClinicalTrials.gov ID: NCT06817577
What this study is testing
What is NG004?
NG004 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for acute spinal cord injury (sci).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Acute incomplete cervical SCI (Neurological level of injury C1 ≤ lesion ≤ C8) with confirmed classification of American Spinal Injury Association...
- 4-28 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 likely can't join 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...
- Other significant pre-existing or current severe systemic disease such as lung, liver (exception: history of uncomplicated Hepatitis A)...
- History of or an acute episode of Multiple Sclerosis or Guillain-Barre syndrome History of recent (6 months) meningitis or meningoencephalitis
See the full eligibility criteria
- 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
- 4-28 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
- 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...
- 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
- Patients who are unconscious
The study team makes the final eligibility decision.
Where it's taking place
- Bayreuth, Germany
- Halle, Germany
- Heidelberg, Germany
- Murnau am Staffelsee, Germany
- Nottwil, Switzerland
- Zurich, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bayreuth, Germany; Halle, Germany; Heidelberg, Germany; Murnau am Staffelsee, Germany; Nottwil, Switzerland; Zurich, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.