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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02363361

Enrollment

Registered

2015-02-16

Start date

2018-04-30

Completion date

2021-12-31

Last updated

2018-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Spinal Cord Injury

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.

Interventions

DRUGImatinib

Day 1. 800 mg, Day 2-14: 2 \* 400 mg per day

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Change in levels of Imatinib in plasma and cytokines in serum day 1-3, 7, 10, 14, 16, 19	Day 1-3, 7, 10, 14, 16, 19

Secondary

Measure	Time frame
Adverse events	Day 1-19

Contacts

Primary ContactMikael Svensson, Prof.MD.PhD

mikael.a.svensson@karolinska.se+46- (0)8-517 716 95

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026