Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT04748705
Status:
COMPLETED
Last Update Posted:
2022-09-27
First Post:
2021-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D010146', 'term': 'Pain'}], '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': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, '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': 'ACTUAL', 'count': 422}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-25', 'studyFirstSubmitDate': '2021-02-05', 'studyFirstSubmitQcDate': '2021-02-05', 'lastUpdatePostDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Pain Score', 'timeFrame': '16 Week', 'description': 'Change from Baseline to Week 16 endpoint in the diary Numerical Rating Scale (NRS) weekly average of daily self-reported average pain severity scores. Scores range from 0 to 10 where a higher score means worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pain'], 'conditions': ['Fibromyalgia']}, 'referencesModule': {'references': [{'pmid': '28260944', 'type': 'BACKGROUND', 'citation': 'Pridgen WL, Duffy C, Gendreau JF, Gendreau RM. A famciclovir + celecoxib combination treatment is safe and efficacious in the treatment of fibromyalgia. J Pain Res. 2017 Feb 22;10:451-460. doi: 10.2147/JPR.S127288. eCollection 2017.'}]}, 'descriptionModule': {'briefSummary': 'Randomized, double-blind, placebo-controlled, 16-week study designed to explore the safety and efficacy of IMC-1 for the treatment of patients with fibromyalgia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient is female, 18 to 65 years of age, inclusive.\n* The patient has a diagnosis of primary FM as defined by the 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria (American College of Rheumatology Preliminary Diagnostic Criteria)\n* The in clinic 7-day recall VAS scale average daily pain intensity score at Screening visit within protocol defined range.\n\nExclusion Criteria:\n\n* Any underlying medical or psychiatric condition that could impact their safe participation per protocol.'}, 'identificationModule': {'nctId': 'NCT04748705', 'acronym': 'FORTRESS', 'briefTitle': 'Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1', 'organization': {'class': 'INDUSTRY', 'fullName': 'Virios Therapeutics, Inc.'}, 'officialTitle': 'A Double-Blinded, Randomized, Placebo-Controlled, Phase 2B Trial of IMC-1 for the Treatment of Fibromyalgia', 'orgStudyIdInfo': {'id': 'PRID-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IMC-1 Oral Tablet', 'description': '2X IMC-1 Tablet taken orally, each morning and evening.', 'interventionNames': ['Drug: IMC-1']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '2X Placebo Tablet taken orally, each morning and evening.', 'interventionNames': ['Drug: Placebo BID Tablet']}], 'interventions': [{'name': 'IMC-1', 'type': 'DRUG', 'description': 'Patients will take 1 tablet twice daily, each morning and evening, of randomly assigned study drug orally starting on Day 1 through study duration.', 'armGroupLabels': ['IMC-1 Oral Tablet']}, {'name': 'Placebo BID Tablet', 'type': 'DRUG', 'description': 'Patients will take 1 tablet twice daily, each morning and evening, of randomly assigned study drug orally starting on Day 1 through study duration.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35216', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'IMC Study Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '72758', 'city': 'Rogers', 'state': 'Arkansas', 'country': 'United States', 'facility': 'IMC Study Site', 'geoPoint': {'lat': 36.33202, 'lon': -94.11854}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'IMC Study Site', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '92503', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'IMC Study 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