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

Professor Mikael Svensson, MD PhD

Status and phase: Unknown; Phase 2

Conditions: Cervical Spinal Cord Injury

Treatments: Drug: Imatinib

Study type: Interventional

Funder types: Other

Identifiers

NCT02363361

EudraCT no 2014-002170-36

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Imatinib

Experimental group

Description:

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

Treatment:

Drug: Imatinib