Cervical Spinal Cord InjuryPhase 2NCT02363361
Treatment of Cervical Spinal Cord Injury With Imatinib - a Safety and Feasibility Study
A Phase 2 study testing Imatinib in people with Cervical Spinal Cord Injury, run by Professor Mikael Svensson, MD PhD.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cervical Spinal Cord Injury
- What is being tested?
- Imatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Apr 2018to Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Cervical Spinal Cord Injury
- Being tested
- Imatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImatinibDrug
Also called Glivec
Day 1. 800 mg, Day 2-14: 2 * 400 mg per day
| Study group | Role | What they receive |
|---|---|---|
| Imatinib | Experimental | Day 1. 800 mg, Day 2-14: 2 * 400 mg per day Receives: Drug: Imatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in levels of Imatinib in plasma and cytokines in serum day 1-3, 7, 10, 14, 16, 19
Measured: Day 1-3, 7, 10, 14, 16, 19
Secondary outcomes (1)
Adverse events
Measured: Day 1-19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2015 (estimated)
- Study startApr 2018 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Professor Mikael Svensson, MD PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Professor Mikael Svensson, MD PhD, Karolinska University Hospital
- Investigators
- Mikael Svensson, Prof.MD.PhD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363361
- Sponsor's protocol ID
- EudraCT no 2014-002170-36
- Status last verified
- Mar 2018
- First submitted
- 3 Feb 2015
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Acute Cervical Spinal Cord Injury With Imatinib (Glivec®) - a Safety and Feasibility Study (EudraCT no 2014-002170-36)
- ClinicalTrials.gov ID
- NCT02363361
- Acronym / sponsor ID
- EudraCT no 2014-002170-36
- Conditions
- Cervical Spinal Cord Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Professor Mikael Svensson, MD PhDUniversity, hospital or other
- Study start
- Apr 2018 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 16 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imatinib | Experimental | Drug: ImatinibDay 1. 800 mg, Day 2-14: 2 * 400 mg per day |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImatinibAlso: GlivecDay 1. 800 mg, Day 2-14: 2 * 400 mg per day | Drug | Imatinib |
Primary outcome
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
1 secondary outcome
Adverse events
Time frame: Day 1-19
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikael Svensson, Prof.MD.PhD principal investigator
Karolinska University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imatinib in people with Cervical Spinal Cord Injury, run by Professor Mikael Svensson, MD PhD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mikael Svensson, Prof.MD.PhD (+46- (0)8-517 716 95, mikael.a.svensson@karolinska.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2018.