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

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) - „Efficacy of Euminz® for Tension-Type Headache“

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004777-89-DE

Enrollment

Unknown

Registered

2011-12-05

Start date

2012-02-28

Completion date

Unknown

Last updated

2016-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Episodic tension-type headache MedDRA version: 18.0 Level: LLT Classification code 10043270 Term: Tension headache (excl migraine) System Organ Class: 100000004852

Interventions

Trade Name: Euminz® Pharmaceutical Form: Cutaneous solution CAS Number: 8006-90-4 Other descriptive name: PEPPERMINT OIL Concentration unit: % (W/W) percent weight/weight Concentration type: equal Con

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of this prospective, multi-centre, double-blind, placebo-controlled, phase IV clinical trial is to demonstrate the efficacy of Euminz to reduce the intensity of headaches symptoms after topical use during episodic headache attack experienced by patients with episodic tension-type headache.;Secondary Objective: Secondary objectives: - further headache attacks will be documented and evaluated during study duration (VPRS, VAS) - sum of pain intensity differences (SPID) will be calculated over all episodes - development of associated pericranial tenderness, esp. neck pain under treatment (physical examination, NDI, NPAD) - use of rescue medication - any other additional therapy for TTH - increase of pain relief measured by verbal pain relief scale (VPRfS) - efficacy of the treatment by a global patient´s assessment - efficacy of the treatment by a global investigator`s assessment - global comparative of treatment by a global investigator`s assessment - further pain development, headache reccurance (240 minutes and 24 hours after treatment, respectively) - safety: Physical examinations, overall assessments both by the patient and the investigator, vital signs, adverse events. ;Primary end point(s): -primary efficacy: -the pain-free rate after two hours -the decrease of intensity of pain measured by a visual analogue scale (VAS). ;Timepoint(s) of evaluation of this end point: -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 a six–step verbal pain rating scale (VPRS). Timepoints: 15, 30, 45, 60, 90 and 120 minutes after start of treatment. Pain-free is defined as 0 or 1 on the VPRS. -The difference from measure point 0 (before first application of Euminz®) on the visual analogue scale (VAS) in comparison to 15, 30, 45, 60, 90 and 120 minutes after start of treatment will be shown as area under the curve representi	—

Measure

Time frame

Main Objective: The main objective of this prospective, multi-centre, double-blind, placebo-controlled, phase IV clinical trial is to demonstrate the efficacy of Euminz to reduce the intensity of headaches symptoms after topical use during episodic headache attack experienced by patients with episodic tension-type headache.;Secondary Objective: Secondary objectives: - further headache attacks will be documented and evaluated during study duration (VPRS, VAS) - sum of pain intensity differences (SPID) will be calculated over all episodes - development of associated pericranial tenderness, esp. neck pain under treatment (physical examination, NDI, NPAD) - use of rescue medication - any other additional therapy for TTH - increase of pain relief measured by verbal pain relief scale (VPRfS) - efficacy of the treatment by a global patient´s assessment - efficacy of the treatment by a global investigator`s assessment - global comparative of treatment by a global investigator`s assessment - further pain development, headache reccurance (240 minutes and 24 hours after treatment, respectively) - safety: Physical examinations, overall assessments both by the patient and the investigator, vital signs, adverse events. ;Primary end point(s): -primary efficacy: -the pain-free rate after two hours -the decrease of intensity of pain measured by a visual analogue scale (VAS). ;Timepoint(s) of evaluation of this end point: -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 a six–step verbal pain rating scale (VPRS). Timepoints: 15, 30, 45, 60, 90 and 120 minutes after start of treatment. Pain-free is defined as 0 or 1 on the VPRS. -The difference from measure point 0 (before first application of Euminz®) on the visual analogue scale (VAS) in comparison to 15, 30, 45, 60, 90 and 120 minutes after start of treatment will be shown as area under the curve representi

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints: -Further headache attacks will be documented and evaluated during the study duration (VPRS, VAS) and described as sum of pain intensity differences (SPID) - Decrease in the intensity of pain after two hours compared to the intensity before the first application measured by a visual analogue scale (VAS) - Sum of pain intensity differences (SPID) will be calculated over all episodes -Development of associated pericranial tenderness, esp. neck pain under treatment (NDI, NPAD-d) -Use of rescue medication after two hours - Any other additional therapy for TTH -Increase of pain relief after the first application measured by a six-step verbal pain relief scale (VPRfS) -Global assessment of the efficacy of the treatment after two hours by the patient of every headache episode; -Global comparative evaluation of the treatment by the patient of every headache episode -Global assessment of the efficacy of the treatment by the investigator after 10 weeks by the investigator -further pain development, headache recurrance (240 minutes and 24 hours after treatment, respectively) -Safety of the treatment ;Timepoint(s) of evaluation of this end point: •VPRS sum of pain intensity differences (SPID) after 15, 30, 45, 60, 90, 120 min. referred to baseline; •Decrease in the intensity of pain after two hours compared to the intensity before the first application measured by a visual analogue scale (VAS); •VAS sum of pain intensity differences (SPID) after 15, 30, 45, 60, 90, 120 min. referred to baseline; •Development of associated pericranial tenderness, esp. neck pain under treatment (NDI, NPAD-d); •Increase of pain relief two hours after the first application measured by a six-step verbal pain relief scale (VPRfS); •VPRfS sum of pain relief scores (TOTPAR) after 15, 30, 45, 60, 90, 120 min.	—

Measure

Time frame

Secondary end point(s): Secondary endpoints: -Further headache attacks will be documented and evaluated during the study duration (VPRS, VAS) and described as sum of pain intensity differences (SPID) - Decrease in the intensity of pain after two hours compared to the intensity before the first application measured by a visual analogue scale (VAS) - Sum of pain intensity differences (SPID) will be calculated over all episodes -Development of associated pericranial tenderness, esp. neck pain under treatment (NDI, NPAD-d) -Use of rescue medication after two hours - Any other additional therapy for TTH -Increase of pain relief after the first application measured by a six-step verbal pain relief scale (VPRfS) -Global assessment of the efficacy of the treatment after two hours by the patient of every headache episode; -Global comparative evaluation of the treatment by the patient of every headache episode -Global assessment of the efficacy of the treatment by the investigator after 10 weeks by the investigator -further pain development, headache recurrance (240 minutes and 24 hours after treatment, respectively) -Safety of the treatment ;Timepoint(s) of evaluation of this end point: •VPRS sum of pain intensity differences (SPID) after 15, 30, 45, 60, 90, 120 min. referred to baseline; •Decrease in the intensity of pain after two hours compared to the intensity before the first application measured by a visual analogue scale (VAS); •VAS sum of pain intensity differences (SPID) after 15, 30, 45, 60, 90, 120 min. referred to baseline; •Development of associated pericranial tenderness, esp. neck pain under treatment (NDI, NPAD-d); •Increase of pain relief two hours after the first application measured by a six-step verbal pain relief scale (VPRfS); •VPRfS sum of pain relief scores (TOTPAR) after 15, 30, 45, 60, 90, 120 min.

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Countries

Germany

Contacts

Public ContactMedical Science Division

Cassella-med GmbH & Co.KG

mwze@cassella-med.de4903072007755

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026