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Treatment of Cervical Spinal Cord Injury with a drug called Imatinib – a study to check the uptake of the study drug in the blood and the safety of the study drug for these patients.

Treatment of Cervical Spinal Cord Injury with Imatinib – a safety and feasibility study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2014-002170-36-SE
Enrollment
Unknown
Registered
2014-12-15
Start date
2015-02-11
Completion date
Unknown
Last updated
2015-02-16

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

Conditions

Cervical Spinal Cord Injury

Interventions

Trade Name: Glivec® Product Name: Imatinib (Glivec®) Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IMATINIB MESILATE CAS Number: 220127-57-1 Concentration unit: mg milligram(s) Concentr

Sponsors

Karolinska University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 9 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1

Exclusion criteria

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, ketokonazol, itrakonazol, erythromycin and claritomycin Dexametason, phenytoin, karbamazepin, rifampizin, phenobarbital, fosphenytoin, primidon, Hypericum performatum (Johannesört). 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

MeasureTime frame
Main Objective: To evaluate the uptake of Imatinib in acute Cervical Spinal Cord Injury patients by measuring blood levels of Imatinib and by observing Imatinib-induced increased levels of three cytokines in blood.;Secondary Objective: To evaluate the safety and tolerability of Imatinib in acute Cervical Spinal Cord Injury patients;Primary end point(s): To detect levels of Imatinib in plasma when given via a feeding tube to patients with cervical spinal cord injury, and to measure change in levels of three cytokines in serum. ;Timepoint(s) of evaluation of this end point: Day 1, 2, 3, 7, 10, 14, 16 and 19—

Secondary

MeasureTime frame
Secondary end point(s): Adverse Events (ADE, SAE, SADE, SUSAR) in patients with cervical spinal cord injury given Imatinib via a feeding tube. ;Timepoint(s) of evaluation of this end point: Day 1-19—

Countries

Sweden

Contacts

Public ContactSponsor

Karolinska University Hospital

mikael.a.svensson@karolinska.se+468517 716 95

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026