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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000584-28 | EudraCT Number |
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| Name | Class |
|---|---|
| Else Kröner Fresenius Foundation | OTHER |
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The Ibuprofen - Spinal Cord Injury (SCI) - Safety trial investigates tolerability and feasibility of "small molecule" (Ibuprofen) mediated Rho-inhibition as putative neuroprotective, plasticity-enhancing and neurorestaurative intervention. The primary safety analysis is based on the incidence of severe gastrointestinal bleedings. In addition, the feasibility of recruitment procedure, and oral administration of the compound within the multidisciplinary setting of acute intensive medical care will be explored. Furthermore, the pharmacokinetics of Ibuprofen under the condition of acute motor complete SCI will be investigated. Secondary endpoints will permit preliminary statements about effects on neuropathic pain, spasticity, and neurological function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dolormin® extra (Ibuprofen) 4 weeks | Active Comparator |
| |
| Dolormin® extra (Ibuprofen) 12 weeks | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dolormin® extra (Ibuprofen) | Drug | Ibuprofen Tablets (as lysine-salt) 2400mg/d (400mg 2-2-2) applied orally for 4 weeks (Arm I; n=6). In order to reduce the risk of damage to the gastrointestinal mucosa Pantoprazole is applied as concomitant medication in a dosage 40mg/d during the treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with severe gastroduodenal bleedings as a measure of safety | Safety of lbuprofen as measured by the occurence of severe gastroduodenal bleedings documented as serious adverse events (SAE) | up to 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Spasticity on the Modified Ashworth Scale (MAS) | 4 weeks and 6 months | |
| Pain on the Neuropathic Pain Scale (NPS) | baseline, 4 weeks and 6 months | |
| International standards for neurological classification of spinal cord injury (ISNCSCI) - ASIA impairment scale (AIS) change from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Heterotopic ossifications | Screening for heterotopic ossifications using sonography of the hip joints | baseline, 4 weeks and 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Niedeggen, MD | Unfallkrankenhaus Berlin, Treatment Centre for Spinal Cord Injuries, Germany | Principal Investigator |
| Jan M Schwab, MD, PhD | Charité, Universitätsmedizin Berlin, Spinal Cord Injury Research, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unfallkrankenhaus Berlin, Treatment Centre for Spinal Cord Injuries, Warener Straße 7 | Berlin | 12683 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27466236 | Derived | Kopp MA, Liebscher T, Watzlawick R, Martus P, Laufer S, Blex C, Schindler R, Jungehulsing GJ, Knuppel S, Kreutztrager M, Ekkernkamp A, Dirnagl U, Strittmatter SM, Niedeggen A, Schwab JM. SCISSOR-Spinal Cord Injury Study on Small molecule-derived Rho inhibition: a clinical study protocol. BMJ Open. 2016 Jul 26;6(7):e010651. doi: 10.1136/bmjopen-2015-010651. |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Dolormin® extra (Ibuprofen) | Drug | Ibuprofen Tablets (as lysine-salt) 2400mg/d (400mg 2-2-2) applied orally for 12 weeks (Arm II, n=6). In order to reduce the risk of damage to the gastrointestinal mucosa Pantoprazole is applied as concomitant medication in a dosage 40mg/d during the first 4 weeks of treatment and may be reduced to 20mg/d during the following treatment period after individual risk-benefit assessment. |
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| baseline, 4 weeks and 6 months |
| Neurological motor function on the ISNCSCI/ASIA motor scores change from baseline | baseline, 4 weeks and 6 months |
| Neurological sensory function on the ISNCSCI/ASIA sensory score change from baseline | baseline, 4 weeks and 6 months |
| Number of participants with adverse events as a measure of safety and tolerability | up to 6 months |
| Ibuprofen levels in plasma | Arm I (day 1 and week 4), Arm II (day 1, week 4 and 12) 1.5 and 3 hours post-dose |
| Ibuprofen levels in cerebrospinal fluid (CSF) | Arm I (day 1 and week 4), Arm II (day 1, week 4 and 12) 3 hours post-dose |
| D014947 | Wounds and Injuries |