Back to resultsTreatment of Cervical Spinal Cord Injury With Imatinib - a Safety and Feasibility Study
Primary Purpose
Cervical Spinal Cord Injury
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Imatinib
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Spinal Cord Injury
Eligibility Criteria
Inclusion Criteria:
- Men and women aged 18-80 years
- Clinical signs of cervical spinal cord injury due to trauma.
- In otherwise good health condition as determined by past medical history, physical examination, laboratory tests and vital signs
- 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:
- Diabetes (type I and II)
- Ongoing cancer treatment
- Known allergy to study drug Imatinib or its excipients
- 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).
- Female subjects lactating or with positive pregnancy test
- Known liver or kidney disease
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Imatinib
Arm Description
Day 1. 800 mg, Day 2-14: 2 * 400 mg per day
Outcomes
Primary Outcome Measures
Change in levels of Imatinib in plasma and cytokines in serum day 1-3, 7, 10, 14, 16, 19
Secondary Outcome Measures
Adverse events
Full Information
NCT ID
NCT02363361
First Posted
February 3, 2015
Last Updated
March 5, 2018
Sponsor
Professor Mikael Svensson, MD PhD
1. Study Identification
Unique Protocol Identification Number
NCT02363361
Brief Title
Treatment of Cervical Spinal Cord Injury With Imatinib - a Safety and Feasibility Study
Official Title
Treatment of Acute Cervical Spinal Cord Injury With Imatinib (Glivec®) - a Safety and Feasibility Study (EudraCT no 2014-002170-36)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 2018 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Professor Mikael Svensson, MD PhD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Spinal Cord Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Imatinib
Arm Type
Experimental
Arm Description
Day 1. 800 mg, Day 2-14: 2 * 400 mg per day
Intervention Type
Drug
Intervention Name(s)
Imatinib
Other Intervention Name(s)
Glivec
Intervention Description
Day 1. 800 mg, Day 2-14: 2 * 400 mg per day
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Adverse events
Time Frame
Day 1-19
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women aged 18-80 years
Clinical signs of cervical spinal cord injury due to trauma.
In otherwise good health condition as determined by past medical history, physical examination, laboratory tests and vital signs
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:
Diabetes (type I and II)
Ongoing cancer treatment
Known allergy to study drug Imatinib or its excipients
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).
Female subjects lactating or with positive pregnancy test
Known liver or kidney disease
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mikael Svensson, Prof.MD.PhD
Phone
+46- (0)8-517 716 95
Email
mikael.a.svensson@karolinska.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikael Svensson, Prof.MD.PhD
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Treatment of Cervical Spinal Cord Injury With Imatinib - a Safety and Feasibility Study
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