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

Cervical Spinal Cord Injury Clinical Trial

Official title:

Treatment of Acute Cervical Spinal Cord Injury With Imatinib (Glivec®) - a Safety and Feasibility Study (EudraCT no 2014-002170-36)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02363361
• Other study ID #: EudraCT no 2014-002170-36
• Status: Not yet recruiting
• Phase: Phase 2
• First received: February 3, 2015
• Last updated: March 5, 2018
• Start date: April 2018
• Est. completion date: December 2021

Study information

• Verified date: March 2018
• Source: Karolinska University Hospital
• Contact: Mikael Svensson, Prof.MD.PhD
• Phone: +46- (0)8-517 716 95
• Email: mikael.a.svensson[@]karolinska.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Spinal Cord Injury
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Drug:
• Imatinib
Day 1. 800 mg, Day 2-14: 2 * 400 mg per day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Professor Mikael Svensson, MD PhD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse events		Day 1-19