Efficacy of Euminz® for Tension-Type Headache (NCT01770080) | Clinical Trial Compass
CompletedPhase 4
Efficacy of Euminz® for Tension-Type Headache
Germany211 participantsStarted 2013-02
Plain-language summary
Efficacy and safety of Euminz® (10% ethanolic solution of peppermint oil for topical use) compared to placebo in patients with episodic tension-type headache (ETTH).
Prospective, double-blind, placebo-controlled, phase IV clinical trial; Parallel-groups design; Randomisation 1:1; First attack per patient will be evaluated for primary objectives, following attacks during study duration will be observed and documented.
Study duration per patient: 10 weeks
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male and female patients from 18 years onwards
* History of ETTH for at least one year. The number of days with such a headache is ≥2 per month
* Onset of TTH below 65 years of age
* At least 10 previous headache attacks fulfilling the following four inclusion criteria:
* Patients with headache attacks lasting from 30 minutes to 7 days
* At least two of the following pain characteristics are present:
* \- Pressing or tightening (non-pulsating) quality
* \- Intensity of pain: moderate = unable to ignore (pain may inhibit, but does not prohibit activities)
* \- Bilateral location
* \- No aggravation by walking stairs or similar routine physical activity
* Headache is not accompanied by nausea or vomiting (anorexia may occur)
* Headache is not accompanied by a combination of the following symptoms: photophobia and phonophobia (only one may be present)
* 3 months retrospective history
* Willingness and ability to keep the patient's diary and to comply with the procedures of the study
* Written informed consent
Exclusion Criteria:
* Headaches other than TTH: (e.g. migraine, cluster headache, hypertension headache, drug-related headache,analgesic-induced headache,post-traumatic headache; associated migraine attacks are permitted if they are well recognized by the patient and if their frequency during the preceding year has not exceeded one per month)
* Presence of oromandibular dysfunction
* History of facial or cranial surgery
* Use of prophylactic drugs f…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
First primary objective of the first headache episode is "pain-free" (0 or 1) after 2 hours measured on a six-step verbal pain rating scale (VPRS).