Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT06066918
Status:
RECRUITING
Last Update Posted:
2025-06-24
First Post:
2023-09-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prophylactic Pregabalin Treatment Following Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}], 'ancestors': [{'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069583', 'term': 'Pregabalin'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-02-01', 'size': 142924, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-01-30T06:17', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'allocation will be sequential. 2 patients will be in the study group, followed by one patient at the control group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-02-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-18', 'studyFirstSubmitDate': '2023-09-28', 'studyFirstSubmitQcDate': '2023-09-28', 'lastUpdatePostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Central pain', 'timeFrame': '1 year', 'description': 'development of central pain by interview (yes /no )'}, {'measure': 'McGill Pain Questionnaire', 'timeFrame': '3 months', 'description': 'Range 0 -78. higher scores mean worse outcome.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spinal Cord Injuries', 'Spinal Cord Diseases']}, 'descriptionModule': {'briefSummary': 'Patients arriving to rehabilitation up to 3 months following SCI will be given (study group) or not (control group) Lyrica (75X2). They will be followed for central pain development.', 'detailedDescription': 'Patients arriving to rehabilitation up to 3 months following SCI will be recruited, if they have not yet developed central pain. Two thirds (the study group) will be treated with Lyrica (Pregabalin75X2) for 3 months. One third (the control group) will not receive preventative treatment. Participants will be followed for central pain development.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Up to 3 months following traumatic or non-traumatic SCL\n* Ability to give informed consent and cooperate\n\nExclusion Criteria:\n\n* Pregnancy\n* Neurological or other medical conditions that may interfere with sensation\n* Neuropathic-like pain before recruitment (described as painful sensation of electric current, burning, numbness, tingling, pricking, or squeezing)\n* Being treated with Pregabalin\n* Blood creatinine levels \\>1.2 or creatinine clearance \\<60\n* Sensitivity to lactose'}, 'identificationModule': {'nctId': 'NCT06066918', 'briefTitle': 'Prophylactic Pregabalin Treatment Following Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'Loewenstein Hospital'}, 'officialTitle': 'The Effect of Preventional Drug Therapy on Pain Regulation Mechanisms Among Spinal Cord Injury Patients Who Have Yet to Develop Central Pain', 'orgStudyIdInfo': {'id': '0012-19-LOE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pregabalin', 'description': 'Pregabalin 75 mg X2', 'interventionNames': ['Drug: Pregabalin 75mg']}, {'type': 'NO_INTERVENTION', 'label': 'No treatment', 'description': 'no treatment'}], 'interventions': [{'name': 'Pregabalin 75mg', 'type': 'DRUG', 'otherNames': ['Lyrica'], 'description': 'Pregabalin 75 mg twice a day', 'armGroupLabels': ['Pregabalin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Raanana', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Sara Lipkin', 'role': 'CONTACT'}], 'facility': 'Loewenstein Rehabilitation Hospital', 'geoPoint': {'lat': 32.1836, 'lon': 34.87386}}], 'centralContacts': [{'name': 'Amiram Catz, Prof.', 'role': 'CONTACT', 'email': 'amiramc@clalit.org.il', 'phone': '972-9-770-9934'}], 'overallOfficials': [{'name': 'Amiram Catz, Catz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Loewenstein Rehabilitation Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loewenstein Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'amiram-catz', 'investigatorAffiliation': 'Loewenstein Hospital'}}}}