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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Charite University, Berlin, Germany
Sponsor:
Collaborator:
Cassella-med GmbH & Co. KG
Information provided by (Responsible Party):
Rainer Stange, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01770080
First received: January 9, 2013
Last updated: June 5, 2013
Last verified: June 2013
  Purpose

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, multi-centre, 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


Condition Intervention Phase
Episodic Tension-Type Headache
Drug: Euminz®
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

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). [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    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) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Safety [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    Physical eximanations, overall assessments both by the patients and the investigator, vital signs, adverse events.


Estimated Enrollment: 186
Study Start Date: February 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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).

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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01770080

Locations
Germany
Charité, Chair of Complementary and Integrative Medicine Recruiting
Berlin, Germany, 14109
Contact: Andreas Michalsen, Professor    03080505691    naturheilkunde@immanuel.de   
Principal Investigator: Andreas Michalsen, Professor         
Sponsors and Collaborators
Charite University, Berlin, Germany
Cassella-med GmbH & Co. KG
Investigators
Study Director: Yatin Shah, MD Charité Berlin
  More Information

No publications provided

Responsible Party: Rainer Stange, Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01770080     History of Changes
Other Study ID Numbers: 2011-004777-89
Study First Received: January 9, 2013
Last Updated: June 5, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Tension-Type Headache
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Peppermint oil
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Parasympatholytics

ClinicalTrials.gov processed this record on July 26, 2014