Table 3.

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.