A clinical trial to demonstrate the efficacy and safety of Euminz® (10% ethanolic solution of peppermint oil for topical use) to reduce the intensity of headache symptoms experienced by patients with episodic tension-type headache compared to placebo

Phase 1

• Conditions: Episodic tension-type headache; MedDRA version: 18.0Level: LLTClassification code 10043270Term: Tension headache (excl migraine)System Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-004777-89-DE
• Lead Sponsor: Cassella-med GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-05
• Last Update Posted: 21 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Male and female patients from 18 years onwards
-History of episodic tension-type headache for at least one year. The number of days with such a headache is =2 per month
-Onset of tension-type headache 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 186
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 186

Exclusion Criteria

-Headaches other than tension-type headache: (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 for headache within one month prior to enrolment
-Use of drugs for acute tension-type headache treatment for = 10 days of headache per month
-Anticipated problems in adhering to the self-observation procedure (e.g. because of work)
-Abuse of alcohol, narcotics or other drugs
-Serious illnesses within the last 3 months (e.g. myocardial infarction, cardiac insufficiency NYHA III and IV, low blood pressure, cerebral insult, diabetes mellitus, neuropathy, changes in the skin or neoplasms in the head)
-Epilepsy
-Intake of anti-psychotic, anti-depressant or anti-epileptic medication during the previous month
-Intake of long-acting non-steroidal anti-inflammatory drugs within the last month
-Planned start of new pharmacological or non-pharmacological therapies
-Any significant skin condition affecting face or neck
-Known hypersensitivity towards peppermint oil
-Previous use of Euminz® or any other essential oil solutions for headache in the last three months
-Participation in another clinical trial within the last month
-Accommodation in an institution at judicial or official request

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified