Efficacy of Euminz® for Tension-Type Headache

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Collaborator: Cassella-med GmbH & Co. KG
• Treatments: Peppermint oil; Pharmaceutical Solutions

Criteria

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 for headache within one month prior to enrolment

• Use of drugs for acute TTH 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