E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients presenting recurrent orofacial herpes infections (6 or more episodes within the 12-months’ period prior to their study entry). |
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E.1.1.1 | Medical condition in easily understood language |
Patients presenting recurrent orofacial herpes infections (6 or more episodes within the 12-months’ period prior to their study entry). |
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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 | 20.0 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10019972 |
E.1.2 | Term | Herpes viral infections |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 | 10067152 |
E.1.2 | Term | Oral herpes |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10019948 |
E.1.2 | Term | Herpes simplex |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 |
Evaluation of the efficacy of 2LHERP® on the reduction of the number of recurrent orofacial herpes infections at 12 months. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives: comparison of the efficacy of 2LHERP® vs placebo according to the following aspects: a) number of episodes at 6 months and 12 months, b) time to first episode during the treatment, c) duration of episodes, d) symptomatology during the entire relapse time, e) use of Rescue Medication (RM), f) evaluation of impact on the quality of life, g) safety issues.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Man or woman aged 18-80 years, - Patient presenting 6 or more episodes of orofacial herpes infections during the preceding 12-months’ period (prior to the study entry), - Woman of childbearing age under effective contraception, - Patient reporting a current stable sexual relationship (steady sexual partner during study duration), - Patient having faculties to understand and respect the constraints of the study, - Signature of the Informed Consent Form.
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E.4 | Principal exclusion criteria |
- Pregnant or breastfeeding woman, - Patient under immunotherapy (including immunosuppressive treatment) or micro-immunotherapy received during last previous 6 months, - Patient who has a suppressive antiviral therapy during last month, - Patient who wishes to continue his/her suppressive antiviral therapy, - Patient with known lactose intolerance, - Patient who participated in a clinical study in the previous 3-month period, - Patient who is not sufficiently motivated to engage on a follow-up period of 12 months, or likely to travel or to move before the end of the study, - Patient with severe immunodeficiency disease requiring long term treatment (*) or under chemotherapy or radiotherapy or corticoid therapy, - Patient under listed homeopathic or phytotherapy treatment, - Patient using or addicted to recreational drugs.
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E.5 End points |
E.5.1 | Primary end point(s) |
Reduction (yes/no) in the number of recurrences of orofacial herpes infection within the 12 months following treatment initiation. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
a.1) Remaining herpes infection recurrence free 12 months after treatment initiation (yes/no), a.2) Remaining herpes infection recurrence free 6 months after treatment initiation (yes/no), a.3) Change from baseline within the number of episodes of herpes infections observed for 12 months, where the baseline value is the number of episodes experienced within the 12 months preceeding study enrolment, a.4) Number of episodes of herpes infection observed at 6 months and at 12 months, b) Time to first recurrence of herpes infection during the treatment, c) Mean duration of episodes, the duration for a given episode being defined as the number of days between the start of the episode and the last day before all symptoms recorded as ‘none’ for 2 consecutive days, in the patient diary, d) Level of pain recorded daily on a visual analogue scale (100mm), as well as other associated symptomatology for orofacial pain (orofacial fissures, difficulties to eat/drink, orofacial pain, fever, QoL), which will be consequently measured as area under the curve (AUC), e) Use of daily rescue medicine (RM), expressed with the cumulative number of days for the treatment period, the follow-up period and the entire study period, f) Quality of life evaluated via a 6-items questionnaire, g) Occurrence of adverse events (AEs) and severe adverse events (SAEs), considered as related or not to the study drug.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
a.1) 12 months, a.2) 6 months , a.3) 12 months, a.4) 6 months and 12 months, b) until 12 months, c) until 12 months, d) until 12 months, e) until 12 months, f) 6 months and 12 months, g) until 6 months. |
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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 | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 13 |
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 | No |
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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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 | 0 |