NCT02096913

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2013

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

October 30, 2017

Status Verified

October 1, 2017

Enrollment Period

4.3 years

First QC Date

March 24, 2014

Last Update Submit

October 26, 2017

Conditions

Spinal Cord Injury

Keywords

Rho-InhibitionPlasticityNeurological FunctionRhoAIbuprofenNSAIDs

Outcome Measures

Primary Outcomes (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)

    up to 4 months

Secondary Outcomes (8)

  • Spasticity on the Modified Ashworth Scale (MAS)

    4 weeks and 6 months

  • Pain on the Neuropathic Pain Scale (NPS)

    baseline, 4 weeks and 6 months

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

    baseline, 4 weeks and 6 months

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

    baseline, 4 weeks and 6 months

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

    baseline, 4 weeks and 6 months

  • +3 more secondary outcomes

Other Outcomes (1)

  • Heterotopic ossifications

    baseline, 4 weeks and 6 months

Study Arms (2)

Dolormin® extra (Ibuprofen) 4 weeks

ACTIVE COMPARATOR
Drug: Dolormin® extra (Ibuprofen)

Dolormin® extra (Ibuprofen) 12 weeks

ACTIVE COMPARATOR
Drug: Dolormin® extra (Ibuprofen)

Interventions

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.

Also known as: Ibuprofen-DL-Lysinsalz
Dolormin® extra (Ibuprofen) 4 weeks

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Berlin, 12683, Germany

Location

Related Publications (1)

  • 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.

    PMID: 27466236DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Andreas Niedeggen, MD

    Unfallkrankenhaus Berlin, Treatment Centre for Spinal Cord Injuries, Germany

    PRINCIPAL INVESTIGATOR

  • Jan M Schwab, MD, PhD

    Charité, Universitätsmedizin Berlin, Spinal Cord Injury Research, Germany

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. Dr.

Study Record Dates

First Submitted

March 24, 2014

First Posted

March 26, 2014

Study Start

June 1, 2013

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

October 30, 2017

Record last verified: 2017-10

Locations

DE(1)