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.

Conditions: Cervical Spinal Cord Injury
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2014-002170-36-SE

Lead Sponsor: Karolinska University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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