Parameter | Assessments/measures | Timing (see also figure 4) | Safety issue |
---|---|---|---|
Primary end point | |||
Gastroduodenal bleeding | SAE report | Continuous observation | Yes |
Secondary end points | |||
Adverse events | Adverse event monitoring, SAE/SUSAR report | Continuous observation | Yes |
Spasticity | Modified Ashworth Scale, antispastic medication | Follow-up 1 and 2 | Yes |
Neuropathic pain | Neuropathic Pain Scale, pain medication | Baseline, follow-up 1 and 2 | Yes |
Severity of SCI | ASIA Impairment Scale | Baseline, follow-up 1 and 2 | No |
Motor function | Upper and lower extremity motor score | Baseline, follow-up 1 and 2 | No |
Sensory function | Pin prick, light touch | Baseline, follow-up 1 and 2 | No |
Lesion height | Motor and sensory level, zone of partial preservation, if applicable | Baseline, follow-up 1 and 2 | No |
Ibuprofen levels | Blood and CSF collection | Pharmacokinetics 1, 2 and 3* | No |
Serum/CSF protein levels | Blood and CSF collection | Pharmacokinetics 1, 2 and 3* | No |
Heterotopic ossifications | Ultrasound of the hip joints, MRI, if applicable | Baseline, follow-up 1 and 2 | No |
Other end points | |||
Laboratory abnormalities | Blood and urine collection | Safety 1, 2, 3 and 4* | Yes |
Cardiac arrhythmia | ECG | Baseline, follow-up 1 and 2 | Yes |
Deep vein thrombosis | Ultrasound of pelvic and lower extremity veins | Baseline, follow-up 1 and 2 | Yes |
Circulatory disturbance | Blood pressure and heart rate | Baseline, safety 1, 2 | Yes |
Clinical observation | Epigastric pain/pain projected to the shoulder tip | Baseline, safety 1, 2 and 3* | Yes |
Feasibility of recruitment | Screening protocol | Screening | No |
Differences between the cohorts are based on the course of an extended intervention. In cohort II, additional pharmacokinetic and safety assessments are scheduled (indicated by asterisks).
ASIA, American Spinal Injury Association; CSF, cerebrospinal fluid; SAE, serious adverse event; SCI, spinal cord injury; SUSAR, serious unexpected suspected adverse reaction.