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

• Status: Not yet recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Professor Mikael Svensson, MD PhD
• Treatments: Imatinib Mesylate

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.

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.