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Safety Study of Ibuprofen to Treat Acute Traumatic Spinal Cord Injury

Information source: Charite University, Berlin, Germany
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Spinal Cord Injury

Intervention: Dolormin® extra (Ibuprofen) (Drug); Dolormin® extra (Ibuprofen) (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Jan M. Schwab, MD, PhD

Official(s) and/or principal investigator(s):
Andreas Niedeggen, MD, Principal Investigator, Affiliation: Unfallkrankenhaus Berlin, Treatment Centre for Spinal Cord Injuries, Germany
Jan M Schwab, MD, PhD, Study Director, Affiliation: Charité, Universitätsmedizin Berlin, Spinal Cord Injury Research, Germany

Overall contact:
Marcel A Kopp, MD, Phone: +49 30 450 560 075, Email: marcel.kopp@charite.de

Summary

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.

Clinical Details

Official title: The Rho-Inhibitor Ibuprofen for the Treatment of Acute Spinal Cord Injury: Investigation of Safety, Feasibility and Pharmacokinetics

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of patients with severe gastroduodenal bleedings as a measure of safety

Secondary outcome:

Spasticity on the Modified Ashworth Scale (MAS)

Pain on the Neuropathic Pain Scale (NPS)

International standards for neurological classification of spinal cord injury (ISNCSCI) - ASIA impairment scale (AIS) change from baseline

Neurological motor function on the ISNCSCI/ASIA motor scores change from baseline

Neurological sensory function on the ISNCSCI/ASIA sensory score change from baseline

Number of participants with adverse events as a measure of safety and tolerability

Ibuprofen levels in plasma

Ibuprofen levels in cerebrospinal fluid (CSF)

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Acute SCI of the cervical spine due to trauma

- Time frame of 4-21 days post-trauma

- Motor complete injury AIS A and B

- Neurological level of the lesion C4-T4

- No participation in a different clinical trial according to German Pharmaceuticals

Act (AMG) 1 month before and during participation in the current trial

- The patient has been informed and his/her written consent has been obtained

- Age: 18 to 65 years

- For women of reproductive age: Negative pregnancy test and highly effective

contraception (defined as Pearl Index < 1) or sexual abstinence during participation in the trial. Exclusion Criteria:

- Multifocal lesions of the spinal cord

- Penetrating spinal cord injury

- Accompanying traumatic brain injury (TBI) with visible structural lesions including

intracranial hemorrhage on diagnostic imagesSigni

- Significant accompanying injury to the peripheral nervous system, particularly plexus

lesions

- Acute or chronic systemic diseases accompanied by neurological deficits or that have

caused permanent neurological deficits which may overlay or hinder the registration of sensomotor functions (e. g. multiple sclerosis, Guillain-Barré syndrome, HIV infection, Lues etc.)

- Malignant neoplasms, except if these are in complete remission.

- Mental diseases or dementia which, in the investigator's opinion, limit the patient's

cooperation in respect of the intake of the study medication and/or significantly hinder the registration of follow-up parameters

- Hemophilia

- Current and persistent misuse of illegal drugs or alcohol

- Hypothermia below 35 C°

- Pregnancy and lactation

- All further contraindications to the study medication, including other ingredients of

the pharmaceutical form according to the Summary of Product Characteristics (SPC)

- Known hypersensitivity to the active substance contained in the concomitant

medication Pantoprazole or one of the components of the drug.

- Intake of Ibuprofen or intake of other active substances from the group of

Nonsteroidal Anti-inflammatory Drugs (NSAIDs; e. g., Diclofenac, Indometacin) or the intake of NSAIDs in maximum recommended daily doses during one week prior to enrolment in the trial

- Simultaneous intake of salicylates, particularly acetylsalicylic acid

- Simultaneous intake of oral anticoagulants, or heparinisation in therapeutic dosage

- Simultaneous intake of systemic glucocorticoids

- Unwilling to consent to storage and transfer of pseudonymized medical data for the

purpose of the clinical trial

- Admitted to an institution by a court or official order (pursuant to AMG §40 (1) 4)

Locations and Contacts

Marcel A Kopp, MD, Phone: +49 30 450 560 075, Email: marcel.kopp@charite.de

Unfallkrankenhaus Berlin, Treatment Centre for Spinal Cord Injuries, Warener Straße 7, Berlin 12683, Germany; Recruiting
Andreas Niedeggen, MD, Phone: +49 30 5681-3401, Email: andreas.niedeggen@ukb.de
Thomas Liebscher, MD, Phone: +49 30 5681-3401, Email: thomas.liebscher@ukb.de
Andreas Niedeggen, MD, Principal Investigator
Additional Information

Starting date: June 2013
Last updated: March 3, 2015

Page last updated: August 23, 2015

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