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

Phase 2

• Conditions: Cervical Spinal Cord Injury
• Interventions: Drug: Imatinib

• Registration Number: NCT02363361
• Lead Sponsor: Professor Mikael Svensson, MD PhD

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-03
• Study First Submitted QC: 2015-02-09
• Study First Posted: 2015-02-16
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-05
• Last Update Posted: 2018-03-07
• Study Start: 2018-04
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Imatinib	Imatinib	Day 1. 800 mg, Day 2-14: 2 \* 400 mg per day

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Adverse events	Day 1-19