Acute Spinal Cord Injury (SCI), Central Nervous System Diseases, Nervous System Diseases, Spinal Cord Diseases, Spinal Cord Injuries (SCI), Trauma, Nervous System, Wounds and Injuries
Conditions
Keywords
Acute spinal cord injury, Nogo-A, SPROUT, Regeneration
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. The trial consists of Part A (the dose escalation) and Part B (the PK-confirmation at 2 dose levels from Part A).
Interventions
DRUGNG004
repeated intrathecal injections of NG004
Sponsors
NovaGo Therapeutics AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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
Exclusion criteria
* 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 * Patients who are unconscious
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Type, frequency, severity, and causal relationship of adverse events (AEs), serious AEs, and adverse drug reactions | From treatment start up to 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Germany, Switzerland
Contacts
CONTACTDirector of Clinical Research
STUDY_DIRECTORDirector of Clinical Research
NovaGo Therapeutics AG
Outcome results
None listed