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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Famciclovir | Drug | Famciclovir (500mg BD) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of famciclovir on Epstein-Barr virus (EBV) shedding | 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. | Baseline to 36 Weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Explore the effect of famciclovir (500mg BD) on serological markers of Epstein-Barr virus (EBV) infection (anti-EBNA-1 and anti-VCA IgG) | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruth Dobson, MA MRCP PhD | Contact | 0207 882 6463 | ruth.dobson@qmul.ac.uk | |
| Lucia Bianchi, PhD | Contact | 020 3594 0637 | l.bianchi@qmul.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal London Hospital, Barts Health NHS Trust | Recruiting | London | E1 1BB | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38131621 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 1, 2023 | |
| Reset | May 9, 2024 | |
| Release | Apr 1, 2025 | |
| Reset | Apr 17, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 1, 2023 | May 9, 2024 | |||
| Apr 1, 2025 |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000077595 | Famciclovir |
| ID | Term |
|---|---|
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Baseline to 36 Weeks |
| Explore the effect of famciclovir (500mg BD) on Epstein-Barr virus (EBV) viral replication in blood | 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 | Baseline to 36 Weeks |
| Apr 17, 2025 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006571 |
| Heterocyclic Compounds |