A Phase 1 interventional study of NG004 and Placebo in Acute Spinal Cord Injury (SCI), Spinal Cord Diseases and Spinal Cord Injuries, sponsored by NovaGo Therapeutics AG. Recruiting at 10 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by NovaGo Therapeutics AG · Phase 1, Interventional, and Treatment
This is a randomized, double-blind, placebo controlled, multicenter trial of NG004 in patients with acute traumatic incomplete cervical SCI. The trial will evaluate the safety and tolerability, PK, and effects on motor function and daily life functioning of NG004 compared with placebo.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's planned enrollment of 120 is above the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →NovaGo Therapeutics AG is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Compared within Spinal Cord Injuries, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Spinal Cord Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: NG004
Other: Placebo
repeated intrathecal injections of NG004 within 30 days
repeated intrathecal injections of Placebo within 30 days
Type, frequency, severity, and causal relationship of adverse events (AEs), serious AEs, and adverse drug reactions
Time frame: From treatment start up to 6 months
NG004 concentration in serum and CSF
Time frame: From treatment start up to 6 months
Effect on neurological recovery according to the International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol as change in ISNCSCI upper extremities motor score (UEMS) and Integrated Neurological Change Score
The ISNCSCI bilateral Upper Extremity Motor Score (UEMS) is determined by examining the muscle function within each of the 5 myotomes encompassing arm and hand function on each side of the body. A score ranging from 0 to 5 can be given to each myotome tested resulting in a maximum score of 50. Higher values indicate better recovery
Time frame: Baseline to 6 months
Effect on daily life functioning as Spinal Cord Independence Measure (SCIM-III)
The SCIM III questionnaire self-care score assesses activities of daily living including feeding, bathing, dressing, and grooming. The self-care score ranges 0-20. The higher scores correspond to better ability to carry out the self-care activities.
Time frame: Month 6
Effect on Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP): strength and prehension performance
The GRASSP is a validated clinical measure of hand function in tetraplegic patients and can assess changes in impairment over time. The GRASSP (Version 2) consists of 4 subtests. The subtest strength (manual muscle testing of 10 muscles of the upper limb) and the subtest prehension performance (grasping test with 4 activities of daily living) will be performed.
Time frame: Month 6
Effect on the Walking Index for Spinal Cord Injury (WISCI II)
WISCI II is a 21-item hierarchical scale of walking based on physical assistance, need of braces and devices, with an ordinal range from 0 (unable to walk) to 20 (walking without assistance for at least 10 meters).
Time frame: Month 6
Effect on 10-meter walking test (10mWT)
10mWT is a quantitative measurement of lower extremity function. The patient shall walk a set distance (10 meters) at preferred walking speed. The distance covered, the time taken, and the assistance used will be recorded.
Time frame: Month 6
Effect on 6-minute walking test (6MWT)
6MWT is a test used to determine the locomotor performance. Patients are instructed to walk as far as possible during 6 minutes, with rests being taken whenever required. The distance covered in time or until abort, the walking time until abort, and the number of rests are assessed.
Time frame: Month 6
Effect on respiratory function: Forced Vital Capacity (FVC) and Forced Expiratory volume in one second (FEV1)
The various lung parameters will include Forced Vital Capacity (FVC), Forced Expiratory volume in one second (FEV1) and peak expiratory flow (PEF). FVC measures volume in Litter delivered during an expiration made as forcefully and completely as possible starting from full inspiration. FEV1 assess the volume measured in Litter delivered in the first second of a FVC maneuver. PEF measures highest flow delivered during FVC maneuver (L/min).
Time frame: Baseline up to 6 months
Effect on respiratory function: Maximal Inspiratory Pressure [MIP] and Maximum Expiratory Pressure [MEP]
Effect on respiratory function measuring respiratory muscle strength: Maximal Inspiratory Pressure \[MIP\] and Maximum Expiratory Pressure \[MEP\]. MIP is assessed as the pressure (in cmH2O) during inhalation against a completely occluded airway and is used to evaluate inspiratory muscle strength. MEP a measure of the strength of expiratory muscles, obtained by having the patient exhale as strongly as possible against a resistance. It is assessed as the pressure (in cmH2O) during exhaling.
Time frame: Baseline up to 6 months
Effect on spinal cord morphology, lesion size, and tissue integrity using magnetic resonance imaging (MRI) scans
MRI scans of the spine will be used to characterize the extent of the lesion from the SCI by assessing morphological measures. Analyses of lesion parameters as preserved tissue bridges, lesion volume, lesion length, lesion width and spinal cord atrophy will be performed. Spinal cord atrophy is measured by calculating the cross-sectional area (CSA) of the spinal cord. Quantitative MRI will be used to assess microstructural tissue integrity, as assed by diffusion tensor imaging and quantitative magnetization transfer saturation mapping.
Time frame: Baseline to 6 months
Effect on muscle spasticity (Modified Ashworth Scale [MAS])
MAS is a 6-point muscle tone assessment scale. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity or increased resistance to passive movement.
Time frame: Month 6
Effect on neuropathic pain (EMSCI Neuropathic Pain Assessment Form [NePAF])
Neuropathic pain will be assessed by the European Multicenter Study About Spinal Cord Injury (EMSCI) Neuropathic Pain Assessment Form (NePAF), which is based on a structured interview using rating scales, and includes specific assessment of the SCI-associated neuropathic pain in terms of location, quality and severity. The pain intensity is rated with an 11-point numeric rating scale with 0 indicating no pain and 10 indicating the worst imaginable pain.
Time frame: Month 6
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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NovaGo Therapeutics AG