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

March 5, 2018 updated by: Professor Mikael Svensson, MD PhD

Treatment of Acute Cervical Spinal Cord Injury With Imatinib (Glivec®) - a Safety and Feasibility Study (EudraCT no 2014-002170-36)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Glivec

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Day 1-3, 7, 10, 14, 16, 19

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: Day 1-19
Day 1-19

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Professor Mikael Svensson, MD PhD

Investigators

  • Principal Investigator: Mikael Svensson, Prof.MD.PhD, Karolinska University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2018

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

February 3, 2015

First Submitted That Met QC Criteria

February 9, 2015

First Posted (Estimate)

February 16, 2015

Study Record Updates

Last Update Posted (Actual)

March 7, 2018

Last Update Submitted That Met QC Criteria

March 5, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT no 2014-002170-36

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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