Trial registration overview
| Data category | Information |
|---|---|
| Primary registry and trial identifying number | ClinicalTrials.gov NCT02096913 |
| Date of registration in primary registry | 24 March 2014 |
| Secondary identifying numbers | 2011-000584-28 |
| Sources of monetary or material support | Charité Universitätsmedizin Berlin, Else Kröner-Fresenius Foundation |
| Primary sponsor | Charitè Universitätsmedizin Berlin, Professor Jan M. Schwab MD, PhD |
| Contact for public queries | Professor Jan M. Schwab MD, PhD (jan.schwab@charite.de) Marcel A. Kopp MD (marcel.kopp@charite.de) |
| Contact for scientific queries | Professor Jan M. Schwab MD, PhD (jan.schwab@charite.de) Marcel A. Kopp MD (marcel.kopp@charite.de) |
| Public title | Safety Study of Ibuprofen to Treat Acute Traumatic Spinal Cord Injury |
| Scientific title | The Rho-Inhibitor Ibuprofen for the Treatment of Acute Spinal Cord Injury: Investigation of Safety, Feasibility and Pharmacokinetics |
| Countries of recruitment | Germany |
| Health conditions or problem studied | Spinal cord injury |
| Interventions | Ibuprofen (Dolormin extra), 2400 mg/day (400 mg 2–2–2) applied orally for 4 weeks (arm I; n=6) or 12 weeks (arm II, n=6) |
| Key inclusion criteria | Acute traumatic SCI; neurologic level C4–Th4; AIS A or B; inclusion at day 4–21 post injury; no participation in another clinical trial; written consent; age 18–65 years; no pregnancy of female participants during trial conduction |
| Key exclusion criteria | Multifocal lesions; penetrating injury; TBI with visible structural lesions; accompanying injury to the peripheral nervous system (plexus lesions); acute or chronic diseases causing/including neurological deficits; malignant neoplasms; significant mental disease or dementia; haemophilia; history of myocardial infarction/stroke; drug abuse; hypothermia below 35°C; pregnancy/lactation; contraindications/hypersensitivity to study medication; current intake of ibuprofen or other NSAIDs or previous intake of maximum doses during 1 week prior to enrolment; intake of salicylates, systemic glucocorticoids, oral anticoagulants or therapeutic heparinisation; no consent to storage and transfer of trial-based data; admittance to institution by court or official order |
| Study type | Interventional; phase I; open label |
| Study activation | 20 June 2013 |
| First patient in | 07 April 2014 |
| Target sample size | 12 |
| Recruitment status | Recruiting |
| Primary outcomes | Severe gastroduodenal bleedings |
| Key secondary outcomes | Spasticity; neuropathic pain; AIS; ISNCSCI/ASIA motor and sensory score; documentation of adverse events; plasma and cerebrospinal fluid ibuprofen level; heterotopic ossifications |
AIS, ASIA Impairment Scale; ASIA, American Spinal Injury Association; ISNCSCI, International Standards for Neurological Classification of Spinal Cord Injury; NSAID, non-steroidal anti-inflammatory drug; SCI, spinal cord injury; TBI, traumatic brain injury.