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 range18 Years – 65 Years
SexALL
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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…
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).