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Sponsor: NovaGo Therapeutics AG
Conditions: Acute Spinal Cord Injury (SCI), Spinal Cord Diseases, Central Nervous System Diseases, Nervous System Diseases, Trauma, Nervous System
Interventions: NG004
Countries: Germany, Switzerland
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).
Sex: ALL
Age: 18 Years to 75 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- Bayreuth, Germany
- Halle, Germany
- Heidelberg, Germany
- Murnau am Staffelsee, Germany
- Nottwil, Switzerland
- Zurich, Switzerland