Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-31 @ 10:01 AM
Study NCT ID:
NCT04239469
Status:
UNKNOWN
Last Update Posted:
2020-01-27
First Post:
2020-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Clinical Trial, Use of KL16-012 in Women With Fibromyalgia Refractary to Conventional Treatment.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D002189', 'term': 'Marijuana Abuse'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-22', 'studyFirstSubmitDate': '2020-01-05', 'studyFirstSubmitQcDate': '2020-01-22', 'lastUpdatePostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Fibromyalgia Impact Questionnaire (FIQ) score', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Numeric score validated in its spanish version, with scores ranging from 0 to 104 and higher values indicating worse symptoms.'}], 'secondaryOutcomes': [{'measure': 'Change in Fibromyalgia Impact Questionnaire (FIQ) score', 'timeFrame': 'Baseline to 2 weeks', 'description': 'Numeric score validated in its spanish version, with scores ranging from 0 to 104 and higher values indicating worse symptoms.'}, {'measure': 'Change in Fibromyalgia Impact Questionnaire (FIQ) score', 'timeFrame': 'Baseline to 4 weeks', 'description': 'Numeric score validated in its spanish version, with scores ranging from 0 to 104 and higher values indicating worse symptoms.'}, {'measure': 'Change in Fibromyalgia Impact Questionnaire (FIQ) score', 'timeFrame': 'Baseline to 8 weeks', 'description': 'Numeric score validated in its spanish version, with scores ranging from 0 to 104 and higher values indicating worse symptoms.'}, {'measure': 'Change in Insomnia Severity Index (ISI) score', 'timeFrame': 'Baseline to 2 weeks', 'description': 'Numeric score validated in its spanish version, with scores ranging from 0 to 28 and higher scores indicating worse insomnia.'}, {'measure': 'Change in Insomnia Severity Index (ISI) score', 'timeFrame': 'Baseline to 4 weeks', 'description': 'Numeric score validated in its spanish version, with scores ranging from 0 to 28 and higher scores indicating worse insomnia.'}, {'measure': 'Change in Insomnia Severity Index (ISI) score', 'timeFrame': 'Baseline to 8 weeks', 'description': 'Numeric score validated in its spanish version, with scores ranging from 0 to 28 and higher scores indicating worse insomnia.'}, {'measure': 'Change in Insomnia Severity Index (ISI) score', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Numeric score validated in its spanish version, with scores ranging from 0 to 28 and higher scores indicating worse insomnia.'}, {'measure': 'Change in pain Visual Analog Scale (VAS) score', 'timeFrame': 'Baseline to 2 weeks', 'description': 'Numeric visual analog scale, with scores ranging from 0 to 10 and higher scores indicating worse pain.'}, {'measure': 'Change in pain Visual Analog Scale (VAS) score', 'timeFrame': 'Baseline to 4 weeks', 'description': 'Numeric visual analog scale, with scores ranging from 0 to 10 and higher scores indicating worse pain.'}, {'measure': 'Change in pain Visual Analog Scale (VAS) score', 'timeFrame': 'Baseline to 8 weeks', 'description': 'Numeric visual analog scale, with scores ranging from 0 to 10 and higher scores indicating worse pain.'}, {'measure': 'Change in pain Visual Analog Scale (VAS) score', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Numeric visual analog scale, with scores ranging from 0 to 10 and higher scores indicating worse pain.'}, {'measure': 'Changes in plasma cytokines', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Quantitative ELISA measurements of plasma levels of IL-6, IL-8, CXCL5, CXCL6, MCP-2, LAP TGFβ-1 and TNFα'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cannabis', 'fibromyalgia', 'phytocannabinoids', 'cannabinoid'], 'conditions': ['Fibromyalgia', 'Cannabis']}, 'descriptionModule': {'briefSummary': 'A double blind randomized placebo controlled trial in 44 women with fibromyalgia and persistent symptoms in spite of use of conventional pharmacotherapy, will be performed in the city of Valparaiso. Patients will be randomized to either placebo or active principle and be followed for 3 months. Assesment of efficacy and safety will be done by measurement of changes in their Fibromyalgia Impact Questionnaire (FIQ) score, Insomnia Severity Index (ISI) score, pain Visual Analogue Scale (VAS) score, plasma cytokine levels and detection of adverse effects.\n\nThe active principle will be a standardized extract of cannabis sativa containing 1 milligram of tetrahydrocannabinol (THC) and 0.45 milligrams cannabidiol (CBD) per drop.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of fibromyalgia based on ACR 2010 criteria\n* FIQ \\> 39 (refractary symptoms)\n* Previous use of at least 2 conventional pharmacotherapies\n\nExclusion Criteria:\n\n* History of substance use disorder\n* History of major psychiatric or cardiovascular diseases\n* Pregnancy\n* Urine THC (+)'}, 'identificationModule': {'nctId': 'NCT04239469', 'briefTitle': 'Phase II Clinical Trial, Use of KL16-012 in Women With Fibromyalgia Refractary to Conventional Treatment.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Knop Laboratorios'}, 'officialTitle': 'Phase II Clinical Trial, Use of KL16-012 in Women With Fibromyalgia Refractary to Conventional Treatment.', 'orgStudyIdInfo': {'id': 'PC003DT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'KL16-012', 'description': 'Patients will use a liquid standardized extract of cannabis sativa. Each drop will contain 1 mg of THC and 0.45 mg of CBD. Administration will be sublingual, while dosing will begin at 3 drops per day and be escalated to 15 drops per day by week 5 according to an escalation chart.', 'interventionNames': ['Drug: KL16-012']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients will use a liquid placebo identical to the active principle in both appearance and taste.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'KL16-012', 'type': 'DRUG', 'otherNames': ['Cannabiol'], 'description': 'Standardized cannabis sativa extract of THC and CBD, with each drop containing 1 mg of THC and 0.45 mg of CBD', 'armGroupLabels': ['KL16-012']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Knop Laboratorios', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}