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Spinal Cord InjuryPhase 1NCT02096913

Safety Study of Ibuprofen to Treat Acute Traumatic Spinal Cord Injury

A Phase 1 study testing Dolormin® extra (Ibuprofen) in people with Spinal Cord Injury, run by Jan M. Schwab, MD, PhD at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Spinal Cord Injury
What is being tested?
Dolormin® extra (Ibuprofen)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteGermany
Study dates
Jun 2013to Sep 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
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  • 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)

Trial locations and contacts

1 site in 1 country.

Germany1 site

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

    Berlin, 12683

Other trials in Germany

About this study

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

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.

Being tested
Dolormin® extra (Ibuprofen)
Keywords
Rho-Inhibition, Plasticity, Neurological Function, RhoA, Ibuprofen, NSAIDs
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dolormin® extra (Ibuprofen)Drug

    Also called Ibuprofen-DL-Lysinsalz

    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.

  • Dolormin® extra (Ibuprofen)Drug

    Also called Ibuprofen-DL-Lysinsalz

    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.

Study groups in NCT02096913
Study groupRoleWhat they receive
Dolormin® extra (Ibuprofen) 4 weeksActive comparatorNot described
Receives: Drug: Dolormin® extra (Ibuprofen)
Dolormin® extra (Ibuprofen) 12 weeksActive comparatorNot described
Receives: Drug: Dolormin® extra (Ibuprofen)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: up to 4 months

Secondary outcomes (8)

  1. Spasticity on the Modified Ashworth Scale (MAS)

    Measured: 4 weeks and 6 months

  2. Pain on the Neuropathic Pain Scale (NPS)

    Measured: baseline, 4 weeks and 6 months

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

    Measured: baseline, 4 weeks and 6 months

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

    Measured: baseline, 4 weeks and 6 months

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

    Measured: baseline, 4 weeks and 6 months

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

    Measured: up to 6 months

  7. Ibuprofen levels in plasma

    Measured: 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)

    Measured: Arm I (day 1 and week 4), Arm II (day 1, week 4 and 12) 3 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2014 (estimated)
  2. Study startJun 2013
  3. Primary completionSep 2017
  4. Study completionSep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02096913
Sponsor's protocol ID
Ibuprofen-SCI-Safety
Other IDs
2011-000584-28
Status last verified
Oct 2017
First submitted
24 Mar 2014
Last updated
30 Oct 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 27466236

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dolormin® extra (Ibuprofen) in people with Spinal Cord Injury, run by Jan M. Schwab, MD, PhD at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with severe gastroduodenal bleedings as a measure of safety (time frame: up to 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02096913, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2017.

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