Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT05283551
Status:
UNKNOWN
Last Update Posted:
2022-03-17
First Post:
2022-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Famciclovir in Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-05-09', 'releaseDate': '2023-12-01'}, {'resetDate': '2025-04-17', 'releaseDate': '2025-04-01'}], 'estimatedResultsFirstSubmitDate': '2023-12-01'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077595', 'term': 'Famciclovir'}], 'ancestors': [{'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2023-11-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-07', 'studyFirstSubmitDate': '2022-02-24', 'studyFirstSubmitQcDate': '2022-03-07', 'lastUpdatePostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Explore the effect of famciclovir (500mg BD) on serological markers of Epstein-Barr virus (EBV) infection (anti-EBNA-1 and anti-VCA IgG)', 'timeFrame': 'Baseline to 36 Weeks', 'description': "Level of serological markers of EBV infection (anti-EBNA-1 IgG and anti-VCA IgG) in particpants' blood in the IMP treatment phase (famciclovir 500mg BD) and post treatment phase of the Study compared with level of serological markers of EBV infection (anti-EBNA-1 IgG and anti-VCA IgG) in the pre-treatment phase of the Study"}, {'measure': 'Explore the effect of famciclovir (500mg BD) on Epstein-Barr virus (EBV) viral replication in blood', 'timeFrame': 'Baseline to 36 Weeks', 'description': "Level of of EBV DNA in particpants' blood in the IMP treatment phase (famciclovir 500mg BD) and post treatment phase of the Study compared with level of EBV DNA in in the pre-treatment phase of the Study"}], 'primaryOutcomes': [{'measure': 'Effect of famciclovir on Epstein-Barr virus (EBV) shedding', 'timeFrame': 'Baseline to 36 Weeks', 'description': 'The primary outcome of this study is quantification of Epstein-Barr virus (EBV) shedding in saliva in the IMP treatment phase (famciclovir 500mg BD) and post treatment phase of the Study compared with Epstein-Barr virus (EBV) shedding in saliva in the pre-treatment phase of the Study Shedding is defined as EBV DNA levels in saliva \\>5.8 copies/ml.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '38131621', 'type': 'DERIVED', 'citation': 'Dobson R, Holden D, Vickaryous N, Bestwick J, George K, Sayali T, Bianchi L, Wafa M, Gold J, Giovannoni G. A phase 2a open-label clinical trial to determine the effect of famciclovir on EBV activity as measured by EBV shedding in the saliva of patients with multiple sclerosis. Mult Scler. 2024 Jan;30(1):63-70. doi: 10.1177/13524585231215268. Epub 2023 Dec 22.'}]}, 'descriptionModule': {'briefSummary': 'This is a proof-of-concept study in 30 patients with established Relapsing Remitting Multiple Sclerosis (RRMS). IMP is Famciclovir. It is a phase II type A open label study. Each individuals participation in the study will last 36 weeks and will be divided into three phases: pre-treatment (12 weeks), treatment with famciclovir (12 weeks), and post-treatment (12 weeks). During the first 12 week phase patients will remain on their usual treatment alone; this will be followed by three months of co-treatment with famciclovir and then followed by a final three months post-famciclovir treatment where participants will continue to take their usual treatment for RRMS. The primary aim is to explore the effect of famciclovir (500mg BD) on Epstein-Barr virus (EBV) shedding in the saliva of patients with MS'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with MS\n* Males and females aged over 18\n* Taking Natalizumab (Tysabri) for the treatment of MS,\n* Be able to provide informed consent to take part in this study.\n* Female patients of childbearing potential (defined in section 13.4) must be willing to follow protocol contraceptive requirements.\n\nExclusion Criteria:\n\n* Taking MS disease modifying treatment other than natalizumab (Tysabri)\n* On no treatment for MS\n* Taking additional immunomodulatory agents (either for MS treatment or other reasons)\n* Has received a course of high dose oral or intravenous steroids within 3 months of study entry. The use of low dose (total daily dose \\<10mg) and/or the use of topical steroids will not act as an exclusion criteria.\n* Taking antiviral or antiretroviral medication for any reason\n* Known allergy to penciclovir, acyclovir, valaciclovir or famciclovir\n* Taking probenecid\n* Significant renal (CKD 3 or 4) and/or liver (ALT\\>3x ULN) impairment\n* Pregnant, or unwilling to take measures to prevent pregnancy\n* Breastfeeding'}, 'identificationModule': {'nctId': 'NCT05283551', 'briefTitle': 'Famciclovir in Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Queen Mary University of London'}, 'officialTitle': 'A Phase 2 Open Label Clinical Trial to Determine the Effect of Famciclovir on Epstein-Barr Virus Activity as Measured by EBV Shedding in Saliva of Patients With Multiple Sclerosis.', 'orgStudyIdInfo': {'id': '249627'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single arm', 'interventionNames': ['Drug: Famciclovir']}], 'interventions': [{'name': 'Famciclovir', 'type': 'DRUG', 'description': 'Famciclovir (500mg BD)', 'armGroupLabels': ['Single arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'E1 1BB', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Ruth Dobson, MA MRCP PhD', 'role': 'CONTACT', 'email': 'ruth.dobson@qmul.ac.uk', 'phone': '0207 882 6463'}, {'name': 'Lucia Bianchi, PhD', 'role': 'CONTACT', 'email': 'l.bianchi@qmul.ac.uk', 'phone': '020 3594 0637'}], 'facility': 'Royal London Hospital, Barts Health NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Ruth Dobson, MA MRCP PhD', 'role': 'CONTACT', 'email': 'ruth.dobson@qmul.ac.uk', 'phone': '0207 882 6463'}, {'name': 'Lucia Bianchi, PhD', 'role': 'CONTACT', 'email': 'l.bianchi@qmul.ac.uk', 'phone': '020 3594 0637'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Queen Mary University of London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-12-01', 'type': 'RELEASE'}, {'date': '2024-05-09', 'type': 'RESET'}, {'date': '2025-04-01', 'type': 'RELEASE'}, {'date': '2025-04-17', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Queen Mary University of London'}}}}