Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-02-27 @ 4:32 PM
Study NCT ID:
NCT01850420
Status:
COMPLETED
Last Update Posted:
2015-03-27
First Post:
2013-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of IMC-1 In Patients With Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-06-11', 'releaseDate': '2021-05-18'}, {'resetDate': '2022-04-21', 'releaseDate': '2022-03-25'}], 'estimatedResultsFirstSubmitDate': '2021-05-18'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D059350', 'term': 'Chronic 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': 'D010146', 'term': 'Pain'}, {'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 143}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-25', 'studyFirstSubmitDate': '2013-05-07', 'studyFirstSubmitQcDate': '2013-05-07', 'lastUpdatePostDateStruct': {'date': '2015-03-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain from baseline', 'timeFrame': '16 weeks', 'description': 'Comparison of the change from baseline in patient self reported pain scores between IMC-1 and placebo treatment, over 16 weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'Patient Global Impression of Change', 'timeFrame': '16 weeks', 'description': 'Patients will rate their global improvement over the duration of the trial'}, {'measure': 'Fibromyalgia Impact Questionnaire', 'timeFrame': '16 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fibromyalgia', 'Myofascial'], 'conditions': ['Fibromyalgia', 'Chronic Pain', 'Myofascial Pain']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, placebo-controlled, 16-week study designed to evaluate the hypothesis that tissue-resident herpes virus may be causally related to fibromyalgia symptoms or recurrence. IMC-1 is a combination treatment that is designed to suppress this suspected virus and thus alleviate fibromyalgia symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of fibromyalgia\n* English speaker\n\nExclusion Criteria:\n\n* Rheumatologic diseases\n* Bipolar disease, OCD, severe anxiety, schizophrenia\n* Systemic infection, severe cardiac disease, chronic steroid usage\n* chronic opioid usage'}, 'identificationModule': {'nctId': 'NCT01850420', 'briefTitle': 'A Study of IMC-1 In Patients With Fibromyalgia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Innovative Med Concepts, LLC'}, 'officialTitle': 'A Double-Blinded, Randomized, Placebo-Controlled, Proof of Concept Phase 2a Study Exploring the Safety and Efficacy of IMC-1 for the Treatment of Patients With Fibromyalgia', 'orgStudyIdInfo': {'id': 'PRID-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IMC-1', 'description': 'Experimental intervention', 'interventionNames': ['Drug: IMC-1']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Matching placebo'}], 'interventions': [{'name': 'IMC-1', 'type': 'DRUG', 'armGroupLabels': ['IMC-1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'IMC Study Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'IMC Study Site', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'IMC Study Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Vista', 'state': 'California', 'country': 'United States', 'facility': 'IMC Study Site', 'geoPoint': {'lat': 33.20004, 'lon': -117.24254}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'IMC Study Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'IMC Study Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'IMC Study Site', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'city': 'Lafayette', 'state': 'Indiana', 'country': 'United States', 'facility': 'IMC Study Site', 'geoPoint': {'lat': 40.4167, 'lon': -86.87529}}, {'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'IMC Study Site', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'IMC Study Site', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'facility': 'IMC Study Site', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'IMC Study Site', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Innovative Med Concepts, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-05-18', 'type': 'RELEASE'}, {'date': '2021-06-11', 'type': 'RESET'}, {'date': '2022-03-25', 'type': 'RELEASE'}, {'date': '2022-04-21', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Innovative Med Concepts, LLC'}}}}