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Treatment of Cervical Spinal Cord Injury With Imatinib - a Safety and Feasibility Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02363361
Recruitment Status : Not yet recruiting
First Posted : February 16, 2015
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Professor Mikael Svensson, MD PhD, Karolinska University Hospital

Brief Summary:
This is a phase II, single center, open-label, non randomized clinical study to assess the uptake, safety and tolerability of Imatinib in acute Cervical Spinal Cord Injury patients. The aim is to determine if Imatinib reaches sufficient blood levels when given to patients with cervical spinal cord injury, via a gastric feeding tube, and also evaluate the safety and tolerability of this drug treatment.

Condition or disease Intervention/treatment Phase
Cervical Spinal Cord Injury Drug: Imatinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Acute Cervical Spinal Cord Injury With Imatinib (Glivec®) - a Safety and Feasibility Study (EudraCT no 2014-002170-36)
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Imatinib
Day 1. 800 mg, Day 2-14: 2 * 400 mg per day
Drug: Imatinib
Day 1. 800 mg, Day 2-14: 2 * 400 mg per day
Other Name: Glivec




Primary Outcome Measures :
  1. Change in levels of Imatinib in plasma and cytokines in serum day 1-3, 7, 10, 14, 16, 19 [ Time Frame: Day 1-3, 7, 10, 14, 16, 19 ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: Day 1-19 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women aged 18-80 years
  2. Clinical signs of cervical spinal cord injury due to trauma.
  3. In otherwise good health condition as determined by past medical history, physical examination, laboratory tests and vital signs
  4. Patient that is conscious and oriented x 4 (regarding date/time, localisation, situation and personal details), with higher level of consciousness, i.e. Glasgow Coma Scale > 14, and is assessed to be competent to give informed consent.

Exclusion Criteria:

  1. Diabetes (type I and II)
  2. Ongoing cancer treatment
  3. Known allergy to study drug Imatinib or its excipients
  4. On current therapy with drugs which may interfere with Imatinib, (e.g. paracetamol, ketoconazole, itraconazole, erythromycin, clarithromycin, dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital, fosphenytoin, primidon, Hypericum perforatum).
  5. Female subjects lactating or with positive pregnancy test
  6. Known liver or kidney disease
  7. Any relevant surgical or medical condition which in the opinion of the investigator may interfere with the conduct of the study or the scientific results. This includes hemorrhagic conditions.

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): NCT02363361


Contacts
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Contact: Mikael Svensson, Prof.MD.PhD +46- (0)8-517 716 95 mikael.a.svensson@karolinska.se

Sponsors and Collaborators
Professor Mikael Svensson, MD PhD
Investigators
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Principal Investigator: Mikael Svensson, Prof.MD.PhD Karolinska University Hospital
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Responsible Party: Professor Mikael Svensson, MD PhD, professor, MD, PhD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT02363361    
Other Study ID Numbers: EudraCT no 2014-002170-36
First Posted: February 16, 2015    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action