Safety Study of Ibuprofen to Treat Acute Traumatic Spinal Cord Injury

Jan M. Schwab, MD, PhD

Status and phase

Completed

Phase 1

Conditions

Spinal Cord Injury

Treatments

Drug: Dolormin® extra (Ibuprofen)

Study type

Interventional

Funder types

Other

Identifiers

NCT02096913

Ibuprofen-SCI-Safety

2011-000584-28 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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
History of myocardial infarction or stroke
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
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)