E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
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 purpose of the study is broadly twofold.
In Part I, to be performed in a controlled laboratory setting, we aim to establish the average speed of onset, and duration, of the skin sensations felt after a single dose.
In Part II, comprising an open-label evaluation when patients use the product to treat tension-type headaches occurring over period of at least 2 weeks, we aim to find out how many wipes they tend to use for each application, and the typical dosing interval.
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E.2.2 | Secondary objectives of the trial |
We also aim to determine subjects' overall level of satisfaction with using 4head, and to test their understanding of the safety information supplied in the Patient Information Leaflet. The latter arises because marketing companies now have a legal obligation to ‘user test’ their in-pack leaflets, and so opportunity is also being taken to obtain some feedback in this regard too. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Male or female subjects will be eligible for inclusion in the study provided they have a declared history of experiencing tension-type headaches at least twice weekly. |
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E.4 | Principal exclusion criteria |
i) Subjects less than 18 years old.
ii) Subjects with a history of known or suspected intolerance to menthol or levomenthol.
iii) Subjects receiving any unlicensed drug within the last 30 days or scheduled to receive an investigative drug other than the study medication during the period of the study.
iii) Subjects who have any other condition, whether being treated or not, which, in the opinion of the Investigator, may adversely influence their participation in the trial.
iv) Female subjects, if they are possibly pregnant or breast-feeding and / or not using a medically approved form of contraception.
v) Subjects considered unable or unlikely to be able to complete the questionnaire/diary or to attend the necessary final visit.
vi) Subjects concurrently participating in any other test involving an Investigational Product.
vii) Subjects who have participated in a research study in the previous 4 weeks involving the same skin site.
viii) Subjects who have any skin pathology, scars, tattoos, or birthmarks at the test site likely to interfere with the study.
ix) Subjects who are an employee of Sequani Clinical or Dermal Laboratories, or an immediate family member (partner, offspring, parents, siblings or sibling’s offspring) of an employee.
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E.5 End points |
E.5.1 | Primary end point(s) |
In Part 1, the analysis variables will be the time to onset, and duration of, the skin sensations.
In Part 2, the analysis variables will be the most appropriate number of wipes per application, and the typical interval time between successive applications (both as reported by subjects), and subjects’ assessments of the effectiveness and acceptability of 4head™ in treating their headaches.
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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 | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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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The study endpoint will occur when the Final Study Report has been signed off, as only by that stage will we be in a position to provide a summary of the study outcome. |
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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 | |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |