Efficacy of Euminz® for Tension-Type Headache (CAS/B/016611)

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); Phase IV Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Episodic Tension-Type Headache
• Intervention / Treatment: Drug: Euminz®; Drug: Placebo

Detailed Description

To demonstrate the efficacy of Euminz® to reduce the intensity of headache symptoms experienced by patients with episodic tension-type headache. The two primary objectives will be tested hierarchically (a-priory ordered) to avoid alpha-adjustment:

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). Acute treatment (3 to 5 time topical use of Euminz®) will start immediately after assessment of a baseline pain intensity of at least moderate pain (3 on VPRS).

Second primary objective of the first headache episode will be the decrease of intensity of pain measured by a visual analogue scale (VAS). The difference from measure point 0 (before first application of Euminz®) on the VAS in comparison to 15, 30, 45, 60, 90 and 120 minutes after start of treatment will be shown as area under the curve representing the pain intensity difference (PID).

• Study Type: Interventional
• Enrollment (Actual): 211
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14109
    • Charité, Chair of Complementary and Integrative Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Euminz®; Acute treatment (3 to 5 time topical use of Euminz® = 10%ethanolic solution of peppermint oil) will start immediately after assessment of a baseline pain intensity of at least moderate pain (3 on VPRS).	Drug: Euminz®; 3 to 5 time topical use of study drug.; Other Names: Peppermint oil (10% ethanolic solution).
Placebo Comparator: Placebo; Acute treatment (3 to 5 time topical use of Placebo= 0,5% ethanolic solution of peppermint oil) will start immediately after assessment of a baseline pain intensity of at least moderate pain (3 on VPRS).	Drug: Placebo; 3 to 5 time topical use of study drug.; Other Names: Peppermint oil (0,5% ethanolic solution).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Acute treatment (3 to 5 time topical use of Euminz®) will start immediately after assessment of a baseline pain intensity of at least moderate pain (3 on VPRS).	2 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Further headache attacks will be documented and evaluated during study duration (VPRS, VAS) and described as sum of pain intensity differences (SPID)	10 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Physical eximanations, overall assessments both by the patients and the investigator, vital signs, adverse events.	48 hours

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: Cassella-med GmbH & Co. KG
• Investigators: Study Director: Yatin Shah, MD, Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: January 9, 2013
• First Submitted That Met QC Criteria: January 15, 2013
• First Posted (Estimate): January 17, 2013

Study Record Updates

• Last Update Posted (Estimate): December 30, 2015
• Last Update Submitted That Met QC Criteria: December 29, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Headache; Tension-Type Headache; Physiological Effects of Drugs; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Peppermint oil; Pharmaceutical Solutions
• Other Study ID Numbers: 2011-004777-89