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

NCT02363361 | Unknown Phase 2

• 1 other identifier: EudraCT no 2014-002170-36
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cervical Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse events

  Day 1-19

Study Arms (1)

Imatinib

EXPERIMENTAL

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

Drug: Imatinib

Interventions

Imatinib DRUG

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

Also known as: Glivec

Imatinib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 18-80 years
• Clinical signs of cervical spinal cord injury due to trauma.
• In otherwise good health condition as determined by past medical history, physical examination, laboratory tests and vital signs
• 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.

You may not qualify if:

• Diabetes (type I and II)
• Ongoing cancer treatment
• Known allergy to study drug Imatinib or its excipients
• 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).
• Female subjects lactating or with positive pregnancy test
• Known liver or kidney disease
• 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.

Sponsors & Collaborators

• Professor Mikael Svensson, MD PhD: lead

MeSH Terms

Interventions

Imatinib Mesylate

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Mikael Svensson, Prof.MD.PhD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mikael Svensson, Prof.MD.PhD

CONTACT

+46- (0)8-517 716 95; mikael.a.svensson@karolinska.se

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor, MD, PhD

Study Record Dates

• First Submitted: February 3, 2015
• First Posted: February 16, 2015
• Study Start: April 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: March 7, 2018

Record last verified: 2018-03