Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 6:35 AM
Study NCT ID:
NCT05622994
Status:
UNKNOWN
Last Update Posted:
2022-11-21
First Post:
2022-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of CB1 Antagonist/Reverse Agonist Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'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': 'D000077285', 'term': 'Rimonabant'}], 'ancestors': [{'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Placebo controlled'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Placebo controlled parallel design'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-14', 'studyFirstSubmitDate': '2022-11-14', 'studyFirstSubmitQcDate': '2022-11-14', 'lastUpdatePostDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events (Safety)', 'timeFrame': '120 days', 'description': 'Number of AE'}, {'measure': 'Biochemical and urine analysis (safety)', 'timeFrame': '120 days', 'description': 'Number of participants with clinically significant abnormal laboratory tests results'}, {'measure': 'ECG (safety)', 'timeFrame': '120 days', 'description': 'Number of participants with clinically significant abnormal ECG readings'}, {'measure': 'Hospital Anxiety and Depression Scale (HAD) (safety', 'timeFrame': '120 days', 'description': 'Range 0-21(higher values more severe)'}, {'measure': 'Modified Ashworth Scale (safety)', 'timeFrame': '90 days', 'description': 'Range 0-4 (higher values more severe)'}, {'measure': 'Penn Scale (safety)', 'timeFrame': '90 days', 'description': 'Range 0-4 (higher values more severe)'}, {'measure': 'Pain numeric rating scale (safety)', 'timeFrame': '90 days', 'description': 'Range 0-10 (higher values more severe)'}, {'measure': 'Questionnaire of falls (safety)', 'timeFrame': '120 days', 'description': 'Number of falls'}, {'measure': '6 min walking test (efficacy)', 'timeFrame': '90 days', 'description': '6 min walking test (meters and number of stops are reported)'}], 'secondaryOutcomes': [{'measure': '10 m test (efficacy)', 'timeFrame': '90 days', 'description': 'Time to walk 10 m (no stops are allowed)'}, {'measure': 'Borg Scale (efficacy)', 'timeFrame': '90 days', 'description': 'Borg Scale punctuation after 6 min waking test. Range 0-10.'}, {'measure': 'Motor Score (efficacy)', 'timeFrame': '90 days', 'description': 'Motor Score (ISNCSCI). Range 0-20 (higher values less severe)'}, {'measure': 'Fatigue Severity Scale (FSS) (Efficacy)', 'timeFrame': '90 days', 'description': 'FSS puntuación. Range 0-7 (higher values more severe)'}, {'measure': 'Patient global impression of changes (PGIC) (efficacy)', 'timeFrame': '90 days', 'description': 'PGIG score. Range 1-7 (higher values indicate worsening)'}, {'measure': 'European Quality of Life -5 Dimensions (EQ-5D) (efficacy)', 'timeFrame': '90 days', 'description': 'EQ-5D questionnaires have 5 dimensions: "Mobility", "Human Autonomy," "Current Activities", "Pain / Discomfort", "Anxiety / Depression" and all dimensions are described by 3 problem levels corresponding to patient response choices (higher values worst). A quality-of-life score is obtained according to the answers to the questionnaires (algorithm to calculate the score in euroqol.org). The maximum score is 1 that indicates excellent quality of life (range for Spanish version 0.5-1).'}, {'measure': 'Health state visual analogically scale (efficacy)', 'timeFrame': '90 days', 'description': 'Range 0-100 mm (higher values indicate higher health state )'}, {'measure': 'Spinal Cord Independence Measures, SCIM (efficacy)', 'timeFrame': '90 days', 'description': 'Range 0-100 (higher values indicate higher independence )'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['walking abilities', 'Rimonabant', 'Endurance', 'Incomplete SCI'], 'conditions': ['Spinal Cord Injuries']}, 'descriptionModule': {'briefSummary': 'This is a placebo controlled study comparing Rimonabant 5 mg per day for 90 days with placebo for the same period. Objective is to improve walking abilities of spinal cord injury individuals (incomplete lesions) and demonstrate that it is a safe treatment in spinal cord injury population.', 'detailedDescription': 'This is a placebo controlled study comparing Rimonabant 5 mg per day for 90 days with placebo for the same period.\n\nMain goal are to test safety and efficacy (impairment of walking abilities teste with the 6 min walking test) of Rimonabant in a specific population (incomplete spinal cord injury).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 yo and \\<75yo\n* Non progressive spinal cord injury\n* Incomplete lesion (AIS C or D)\n* Neurological level between C4 and L1\n* Chronic stage (\\>1 year since injury)\n* Preserved walking ability for at least 5 m (aid allowed)\n* Capability to provide informed consent\n* For fertile women, possibility to use anti conceptive methods\n\nExclusion Criteria:\n\n* Age \\<18 yo or \\>75\n* AIS A, B or E\n* Neurological level above C4 or below L1\n* Subacute stage (\\<1 year since injury)\n* Preserved walking ability for less than 5 m (aid allowed)\n* Pregnancy or breast feeding\n* For fertile women, impossibility to use anti conceptive methods\n* anticoagulant treatment\n* Hypothyroidism\n* Severe bone, kidney or liver disfunction\n* Impossibility to reach the hospital\n* Impossibility to rovide informed consent'}, 'identificationModule': {'nctId': 'NCT05622994', 'acronym': 'RIMOFATSCI-2', 'briefTitle': 'Effects of CB1 Antagonist/Reverse Agonist Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Nacional de Parapléjicos de Toledo'}, 'officialTitle': 'Efectos de un Antagonista/Agonista Inverso Del Receptor CB1 (Rimonabant) Sobre la Capacidad Para la deambulación en Lesionados Medulares Incompletos', 'orgStudyIdInfo': {'id': 'FHNP-CT003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Rimonabant', 'description': 'Rimonabant 5mg', 'interventionNames': ['Drug: Rimonabant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Rimonabant']}], 'interventions': [{'name': 'Rimonabant', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Rimonabant 5mg per day is administered for 90 days. The comparator is placebo for the same duration.', 'armGroupLabels': ['Placebo', 'Rimonabant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45004', 'city': 'Toledo', 'country': 'Spain', 'facility': 'Hospital Nacional de Paraplejicos', 'geoPoint': {'lat': 39.8581, 'lon': -4.02263}}], 'centralContacts': [{'name': 'Antonio Oliviero, MD, PhD', 'role': 'CONTACT', 'email': 'antonioo@sescam.jccm.es', 'phone': '+34925247700', 'phoneExt': '47120'}], 'overallOfficials': [{'name': 'Antonio Oliviero, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Nacional de Parapléjicos'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Nacional de Parapléjicos de Toledo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Antonio Oliviero', 'investigatorFullName': 'Antonio Oliviero', 'investigatorAffiliation': 'Hospital Nacional de Parapléjicos de Toledo'}}}}