E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Epstein Barr virus infection in people with multiple sclerosis. |
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E.1.1.1 | Medical condition in easily understood language |
Epstein Barr virus infection in people with multiple sclerosis. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10028245 |
E.1.2 | Term | Multiple sclerosis |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10014077 |
E.1.2 | Term | EBV infection |
E.1.2 | System Organ Class | 100000004862 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary aim of this study is to explore the effect of famciclovir (500mg twice daily) on Epstein Barr virus shedding in the saliva of people with MS. |
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E.2.2 | Secondary objectives of the trial |
An exploratory aim is to explore the effect of famciclovir (500mg twice daily) on serological markers of Epstein Barr virus (EBV) infection and evidence of the virus in blood.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
People with MS aged over 18 who are taking Natalizumab (Tysabri) will be eligible for inclusion in this study. Participants must be able to provide informed consent to take part in this study.
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E.4 | Principal exclusion criteria |
People with MS who are taking interferon-beta preparations or teriflunomide will not be eligible for this study. People taking fingolimod, cladribine, alemtuzumab or ocrelizumab will be excluded. People with MS who are on additional immunomodulatory agents (either for MS treatment or other reasons) will not be eligible to take part in this study. Participants will be excluded if they have had a course of steroids within 3 months of study entry. People who are already taking antiviral or antiretroviral medication for any reason will be excluded from this study. People known to be allergic to penciclovir, acyclovir, valaciclovir or famciclovir will be excluded from the study. People taking probenecid will be excluded. People with significant renal (CKD 3 or 4) and/or liver impairment will not be eligible to take part in this study. People who are pregnant or breastfeeding will be excluded from this study, and those who are planning to become pregnant or unwilling to take precautions to prevent pregnancy will not be eligible to take part. People who are unable to provide informed consent for any reason will not be eligible to enter this study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome of this study will be suppression of EBV shedding in saliva. Shedding is defined as EBV DNA levels in saliva >5.8 copies/ml.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Weekly saliva samples will be taken. We have previously demonstrated that there is significant variability in EBV shedding in saliva in people with MS over time. The endpoint will therefore be determined throughout the time that the participants are taking famciclovir (12 weeks). |
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E.5.2 | Secondary end point(s) |
There are no secondary endpoints for this study. All other endpoints are exploratory. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
pre-post single arm trial (unblinded) |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Pre-treatment period (12 weeks) |
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E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LVLS plus 3 months to allow for laboratory and statistical analysis to be completed. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 31 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 3 |