- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02363361
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
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.
Study Contact
- Name: Mikael Svensson, Prof.MD.PhD
- Phone Number: +46- (0)8-517 716 95
- Email: mikael.a.svensson@karolinska.se
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
16 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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
|
Day 1. 800 mg, Day 2-14: 2 * 400 mg per day
Other Names:
|
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.
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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-
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