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Completed

NCT Number: NCT02096913

Safety Study of Ibuprofen to Treat Acute Traumatic Spinal Cord Injury

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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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Unfallkrankenhaus Berlin, Treatment Centre for Spinal Cord Injuries, Warener Straße 7

Berlin, 12683, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: Ibuprofen-DL-Lysinsalz

Primary outcomes

  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 outcomes

  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 outcomes

  1. Heterotopic ossifications

    Time frame: baseline, 4 weeks and 6 months

    Screening for heterotopic ossifications using sonography of the hip joints

Sponsors and collaborators

Lead sponsor

Jan M. Schwab, MD, PhD

Other

Collaborators

  • Else Kröner Fresenius Foundation

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Mar 26, 2014
Registry last updated
Oct 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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