Multiple SclerosisPhase 2NCT05283551
Famciclovir in Multiple Sclerosis
A Phase 2 study testing Famciclovir in people with Multiple Sclerosis, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Famciclovir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Nov 2020to 25 Nov 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with MS
- Males and females aged over 18
- Taking Natalizumab (Tysabri) for the treatment of MS,
- Be able to provide informed consent to take part in this study.
- Female patients of childbearing potential (defined in section 13.4) must be willing to follow protocol contraceptive requirements.
Who cannot join
- Taking MS disease modifying treatment other than natalizumab (Tysabri)
- On no treatment for MS
- Taking additional immunomodulatory agents (either for MS treatment or other reasons)
- 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.
- Taking antiviral or antiretroviral medication for any reason
- Known allergy to penciclovir, acyclovir, valaciclovir or famciclovir
Show all 10Show fewer
- Taking probenecid
- Significant renal (CKD 3 or 4) and/or liver (ALT>3x ULN) impairment
- Pregnant, or unwilling to take measures to prevent pregnancy
- Breastfeeding
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal London Hospital, Barts Health NHS Trust
London, E1 1BB
Ruth Dobson, MA MRCP PhD, 0207 882 6463, ruth.dobson@qmul.ac.uk
Lucia Bianchi, PhD, 020 3594 0637, l.bianchi@qmul.ac.uk
About this study
Official title: 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.
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
- Conditions
- Multiple Sclerosis
- Being tested
- Famciclovir
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FamciclovirDrug
Famciclovir (500mg BD)
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Not described Receives: Drug: Famciclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 36 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start25 Nov 2020
- Primary completion25 Nov 2023 (estimated)
- Study completion25 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283551
- Sponsor's protocol ID
- 249627
- Status last verified
- Feb 2022
- First submitted
- 24 Feb 2022
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38131621
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05283551
- Acronym / sponsor ID
- 249627
- Conditions
- Multiple Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 25 Nov 2023 (estimated)
- Study completion
- 25 Nov 2023 (estimated)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Drug: Famciclovir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with MS
- Males and females aged over 18
- Taking Natalizumab (Tysabri) for the treatment of MS,
- Be able to provide informed consent to take part in this study.
- Female patients of childbearing potential (defined in section 13.4) must be willing to follow protocol contraceptive requirements.
Key exclusion criteria (10 listed)
- Taking MS disease modifying treatment other than natalizumab (Tysabri)
- On no treatment for MS
- Taking additional immunomodulatory agents (either for MS treatment or other reasons)
- 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.
- Taking antiviral or antiretroviral medication for any reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FamciclovirFamciclovir (500mg BD) | Drug | Single arm |
Primary outcome
Effect of famciclovir on Epstein-Barr virus (EBV) shedding
Time frame: Baseline to 36 Weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Derived from this study: PubMed 38131621Dobson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Famciclovir in people with Multiple Sclerosis, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruth Dobson, MA MRCP PhD (0207 882 6463, ruth.dobson@qmul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of famciclovir on Epstein-Barr virus (EBV) shedding (time frame: Baseline to 36 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05283551, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.