Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2026-02-20 @ 4:45 PM
Study NCT ID:
NCT02363361
Status:
UNKNOWN
Last Update Posted:
2018-03-07
First Post:
2015-02-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Cervical Spinal Cord Injury With Imatinib - a Safety and Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068877', 'term': 'Imatinib Mesylate'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-05', 'studyFirstSubmitDate': '2015-02-03', 'studyFirstSubmitQcDate': '2015-02-09', 'lastUpdatePostDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in levels of Imatinib in plasma and cytokines in serum day 1-3, 7, 10, 14, 16, 19', 'timeFrame': 'Day 1-3, 7, 10, 14, 16, 19'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'Day 1-19'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Spinal Cord Injury']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Men and women aged 18-80 years\n2. Clinical signs of cervical spinal cord injury due to trauma.\n3. In otherwise good health condition as determined by past medical history, physical examination, laboratory tests and vital signs\n4. 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.\n\nExclusion Criteria:\n\n1. Diabetes (type I and II)\n2. Ongoing cancer treatment\n3. Known allergy to study drug Imatinib or its excipients\n4. 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).\n5. Female subjects lactating or with positive pregnancy test\n6. Known liver or kidney disease\n7. 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.'}, 'identificationModule': {'nctId': 'NCT02363361', 'briefTitle': 'Treatment of Cervical Spinal Cord Injury With Imatinib - a Safety and Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'Treatment of Acute Cervical Spinal Cord Injury With Imatinib (Glivec®) - a Safety and Feasibility Study (EudraCT no 2014-002170-36)', 'orgStudyIdInfo': {'id': 'EudraCT no 2014-002170-36'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Imatinib', 'description': 'Day 1. 800 mg, Day 2-14: 2 \\* 400 mg per day', 'interventionNames': ['Drug: Imatinib']}], 'interventions': [{'name': 'Imatinib', 'type': 'DRUG', 'otherNames': ['Glivec'], 'description': 'Day 1. 800 mg, Day 2-14: 2 \\* 400 mg per day', 'armGroupLabels': ['Imatinib']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mikael Svensson, Prof.MD.PhD', 'role': 'CONTACT', 'email': 'mikael.a.svensson@karolinska.se', 'phone': '+46- (0)8-517 716 95'}], 'overallOfficials': [{'name': 'Mikael Svensson, Prof.MD.PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Professor Mikael Svensson, MD PhD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'professor, MD, PhD', 'investigatorFullName': 'Professor Mikael Svensson, MD PhD', 'investigatorAffiliation': 'Karolinska University Hospital'}}}}