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Safety Study of Ibuprofen to Treat Acute Traumatic Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT02096913
Recruitment Status : Completed
First Posted : March 26, 2014
Last Update Posted : October 30, 2017
Sponsor:
Collaborator:
Else Kröner Fresenius Foundation
Information provided by (Responsible Party):
Jan M. Schwab, MD, PhD, Charite University, Berlin, Germany

Brief 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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Drug: Dolormin® extra (Ibuprofen) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Rho-Inhibitor Ibuprofen for the Treatment of Acute Spinal Cord Injury: Investigation of Safety, Feasibility and Pharmacokinetics
Actual Study Start Date : June 2013
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Dolormin® extra (Ibuprofen) 4 weeks Drug: Dolormin® extra (Ibuprofen)

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.

Other Name: Ibuprofen-DL-Lysinsalz

Active Comparator: Dolormin® extra (Ibuprofen) 12 weeks Drug: Dolormin® extra (Ibuprofen)

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.

Other Name: Ibuprofen-DL-Lysinsalz




Primary Outcome Measures :
  1. Number of patients with severe gastroduodenal bleedings as a measure of safety [ Time Frame: up to 4 months ]
    Safety of lbuprofen as measured by the occurence of severe gastroduodenal bleedings documented as serious adverse events (SAE)


Secondary Outcome Measures :
  1. Spasticity on the Modified Ashworth Scale (MAS) [ Time Frame: 4 weeks and 6 months ]
  2. Pain on the Neuropathic Pain Scale (NPS) [ Time Frame: baseline, 4 weeks and 6 months ]
  3. International standards for neurological classification of spinal cord injury (ISNCSCI) - ASIA impairment scale (AIS) change from baseline [ Time Frame: baseline, 4 weeks and 6 months ]
  4. Neurological motor function on the ISNCSCI/ASIA motor scores change from baseline [ Time Frame: baseline, 4 weeks and 6 months ]
  5. Neurological sensory function on the ISNCSCI/ASIA sensory score change from baseline [ Time Frame: baseline, 4 weeks and 6 months ]
  6. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: up to 6 months ]
  7. Ibuprofen levels in plasma [ Time Frame: Arm I (day 1 and week 4), Arm II (day 1, week 4 and 12) 1.5 and 3 hours post-dose ]
  8. Ibuprofen levels in cerebrospinal fluid (CSF) [ Time Frame: Arm I (day 1 and week 4), Arm II (day 1, week 4 and 12) 3 hours post-dose ]

Other Outcome Measures:
  1. Heterotopic ossifications [ Time Frame: baseline, 4 weeks and 6 months ]
    Screening for heterotopic ossifications using sonography of the hip joints



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02096913


Locations
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Germany
Unfallkrankenhaus Berlin, Treatment Centre for Spinal Cord Injuries, Warener Straße 7
Berlin, Germany, 12683
Sponsors and Collaborators
Jan M. Schwab, MD, PhD
Else Kröner Fresenius Foundation
Investigators
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Principal Investigator: Andreas Niedeggen, MD Unfallkrankenhaus Berlin, Treatment Centre for Spinal Cord Injuries, Germany
Study Director: Jan M Schwab, MD, PhD Charité, Universitätsmedizin Berlin, Spinal Cord Injury Research, Germany

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jan M. Schwab, MD, PhD, Prof. Dr. Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02096913     History of Changes
Other Study ID Numbers: Ibuprofen-SCI-Safety
2011-000584-28 ( EudraCT Number )
First Posted: March 26, 2014    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017
Keywords provided by Jan M. Schwab, MD, PhD, Charite University, Berlin, Germany:
Rho-Inhibition
Plasticity
Neurological Function
RhoA
Ibuprofen
NSAIDs
Additional relevant MeSH terms:
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Ibuprofen
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action