search
Back to results

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

Primary Purpose

Episodic Tension-Type Headache

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Euminz®
Placebo
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Episodic Tension-Type Headache

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charité, Chair of Complementary and Integrative Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Euminz®

Placebo

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
January 9, 2013
Last Updated
December 29, 2015
Sponsor
Charite University, Berlin, Germany
Collaborators
Cassella-med GmbH & Co. KG
search

1. Study Identification

Unique Protocol Identification Number
NCT01770080
Brief Title
Efficacy of Euminz® for Tension-Type Headache
Acronym
CAS/B/016611
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Cassella-med GmbH & Co. KG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Episodic Tension-Type Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
211 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Euminz®
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Euminz®
Other Intervention Name(s)
Peppermint oil (10% ethanolic solution).
Intervention Description
3 to 5 time topical use of study drug.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Peppermint oil (0,5% ethanolic solution).
Intervention Description
3 to 5 time topical use of study drug.
Primary Outcome Measure Information:
Title
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).
Description
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).
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Further headache attacks will be documented and evaluated during study duration (VPRS, VAS) and described as sum of pain intensity differences (SPID)
Time Frame
10 weeks
Other Pre-specified Outcome Measures:
Title
Safety
Description
Physical eximanations, overall assessments both by the patients and the investigator, vital signs, adverse events.
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yatin Shah, MD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Charité, Chair of Complementary and Integrative Medicine
City
Berlin
ZIP/Postal Code
14109
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Euminz® for Tension-Type Headache

We'll reach out to this number within 24 hrs